LASIK

Home     About Us     Contact Us     Post LASIK Help     LASIK Lawyers     Bad LASIK News     Hurt LASIK Patient Forum    What is Lasik
Post LASIK Horror Stories     Post LASIK Complications    My Personal Story     LASIK Videos     Dr. Nick Caro Banned From LASIK     

-Hurt Lasik Patient's Warning You To First Measure All Known Risks Of Every LASIK Irreversible Surgery-
(Scroll down below to see THOUSANDS of stories of hurt LASIK patients warning you)

-Think LASIK Is Safe In 2012-
Below are FDA Medwatch cases, detailing permanent injuries to patients, most of which are coming in this year!!

Until real understanding of the human being is incorporated into the world of medicine, and not just collections of body parts, with all kinds of disease labels thrown at people by other people, doctors, and media--great perpetuation of fears and all kinds of pills, tests, procedure, and surgeries are being generated without the real higher wisdom that we should be incorporating in health promotion and care.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037798  

I had lasik surgery on my left eye only despite my ophthalmologist's urging that i do both eyes. I had read of the possibility that i would see an aura around lights at night after surgery and did not want to take the chance that would happen on both eyes. I had it done on my eye with the worse vision, 14 diopters. After it was done my vision in that eye was about 1 diopter. It progressed to 3. 5 diopters fairly rapidly and is now at 6. 5 diopters. My complaint is that i read in an ophthalmology text book about six months after the surgery that surgery was not recommended for people with vision of 8 diopters or worse and also that it was not recommended for people of my age. I had the surgery done at a med ctr and the physician should have known this info, but he did not inform me even though i did ask the questions.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037799  

 

I had lasik surgery and did not require glasses to read while driving. I only needed glasses for close reading. After 2007, i realized that this was changing. I needed glasses for more things and my vision was degrading to returning to need glasses fulltime and at the same prescription before the laser surgery. I contacted the dr. 's office where it was done for a followup and this change and was told that if it had to be "redone" i would again have to pay for another surgery as the time was past the "two years". I then went to an ophthalmologist and was told that my glasses were of the same strength, of the ones i wore before the surgery, and that i had a cornea problem and had stages of cataracts. I was shocked since i thought that the exam at the time of the surgery would have shown these problems and would have shown perhaps an alternate type of surgery, or addressing this condition first. Vision after laser surgery and correction did not sustain.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037800  

 

Within a month of my lasik procedure my night driving became impaired by starbursts which were made worse if it was raining. I had to wear very low-prescription, non-glare coated glasses for night driving. Also, the surgery couldn't completely correct my astigmatism, and in the last year my vision got worse, so i am back in glasses every day now. I had a very good doctor and he warned me of all of this, so none of it really surprises me, though it does disappoint me that my only option is to have the procedure again and the results would presumably be better given that the procedure is more precise now than it was 9 years ago. Lasik procedure on both eyes in 1999.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037803  

 

I had lasik and it resulted in permanent halos, loss of night vision, and dry-eye. The dry-eye is mild and has improved with time, but has continued. The halos and night vision are severe. I have larger than average pupils, and i've been told that the problem is that they expand to be larger than the surgical scar, which causes light to refract and cause a halo or aura around lights or light-colored objects in dim light. Dim light basically means anything less than very bright sunlight. I used to have unusually good night vision, and it's far more limited now, that's what i regret the most. My measured vision regressed after the fact, but i expected that - it was very bad before. I still wear glasses, but at a much lesser prescription. I don't count that as an adverse reaction, but i do think that many people don't realize that if you have terrible vision to begin with you are less likely to get perfect vision from the surgery. I did know that and accepted it. Due to the halos, i could not drive at night for years, and i only risk it now because i've been able to get much better anti-glare for my glasses that helps a lot. The major problem that i have now is that i can't read street signs until i'm very close because the white wording blurs due to halos. Also, pupils shrink as you age, so that may have helped. My doctor spent a lot of time with me and was very thorough before and after - i don't blame him for this problem. I was warned that i had a higher likelihood than normal to get the long-term halo effects, but was also told it was unlikely. I did not know exactly what the halos wee, and i do not think people realized how likely they were with my type of eye structure at the time. The halo effect and loss of night vision have had a permanent adverse effect on my life and ability to function. I think people should be warned about how troublesome this is, and that there should possibly be stricter guidelines against people with large pupils having this surgery, at least until they figure out how to lessen the chances of this happening. Maybe some sort of drawing or film could be made showing what they might end up seeing at night to explain what the halos are could help. My doctor was very careful about measuring how thick my corneas were before agreeing to do the surgery - maybe pupil size should be an add'l first check. Lasik surgery, 1999.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037804  

 

After having lasik surgery on my left eye, which was -13, or about 20/200-, my vision seemed to have improved. However, since the removal of the eye patch, the vision has had a "pulsating" sensation in which objects are almost in focus, then get grossly out of focus every second or so. This is constant. Plus, i have perpetual halos and flares at night as well as extreme dry eye. I've since learned from other ophthalmologists that the surgeon had over-corrected and the cornea is now permanently flat, rather than curved. They also told me that i should've been rejected as a candidate due to my extreme myopia. I'm thankful that i had the foresight - no pun intended - to have him operate on only one eye and not both. My reasoning was that if the surgery went well, i'd have him do the right eye.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037806  

 

Got lasik. I now have large, distracting halos around bright light sources - hi contrast. Especially noticeable at night. I also have a large number of "floaters" in my eyes. I believe these are free, coagulated blood cells, but not sure. They are especially noticeable when looking at a evenly lit, uniform surface, such as a clear blue sky or a white wall. I would estimate about 10 distinct floaters in each eye. I also suffer from very dry eyes - i tend to use eye drops before i go to bed and when i wake up. I can barely keep my eyes open when i first wake-up, they are that dry. I use an over the counter eye lubricant prod. I am a photographer, so some of these uncomfortable adverse effects are very noticeable to me, and i sometimes feel like they are driving me crazy.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037807  

 

Although i'm not certain about the date of my lasik eye surgery, there were problems from this surgery. Initially, the doctor reversed the monovision, mistakenly treating my right eye for near vision and my left eye for distance. Afterwards, when i couldn't see clearly, the doctor realized his mistake so he repeated the surgery on my right eye to make it for distance, too. Therefore, i didn't end up with monovision because of his mistake. Another problem was that my vision was approx 20/40 in one eye and 20/30 in the other until approx two yrs after the surgery. The doctor advised me to put drops in my eyes every day to dilate my pupils, so i could see better. He said i would need to wear sunglasses because of the light entering my eyes from this dilation. Needless to say, i didn't do this ridiculous procedure! however, after approx two yrs, my vision has improved to an acceptable level. This litany of problems sound like i went to a fly-by-night clinic, however, i went to a respected ophthalmologist.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037808  

 

Had lasik surgery. Adverse results include extreme dry eye (has eased somewhat, especially with the use of flaxseed oil pills), starbursts, halos, double-vision and lack of contrast. Vision varies greatly based on the amount of light - much worse at night and in dim light - and amount of moisture in the eye. Each blink can produce a different quality of vision. If there is someone standing in front of me in dim light, and there is brighter light behind them, i can hardly see what's in the foreground. Even with the aid of glasses or contacts, my vision can no longer be corrected to that i had before. If i could go back and do it again, i would not have the surgery. I was probably a poor candidate, with large pupils and poor vision - 6. 5, but no one mentioned that at the time. One realy frustrating thing is that the eye tests indicate my vision is much better than what i know to be true, because they don't measure the effect of the starbursts, etc. , and they don't test night vision.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037809  

 

One eye was only corrected to half the vision it should have been. The flap on the other eye was not smoothed out resulting in wrinkles on the flap that cause impaired vision. I have terrible night vision, see halos and starbursts around every bright light. In very muddled light vision is very difficult. Dry eyes are very common and i suffer from that.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037810  

 

Lasik surgery was done on both eyes. Monovision was chosen so that i could read out of right eye - i had been using monovision contacts. Surgery resulted in double vision in left eye which is the distance eye. This means i still need to wear glasses while driving. Traffic lights and headlights appear double and blurry. Also now have dry eyes. The positive side is that i feel safe when sailing or swimming. I was legally blind without contacts before. I went back to the dr and she said that the result is fine. I disagree but am afraid to get it adjusted.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037811  

 

Cataract surgery with lasik touchup resulted in very poor night vision and substantial increase in floaters.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037812  

 

I got lasik eye surgery in early 2006 - (that's not the exact date), i have no vision issues, thank god, but what i do have is permanent dry eye disorder. The dry eye disorder is hell at times, it's very painful and i get headaches, it is disabling because i have a lot of trouble working a full day, because the ventilation and wind hitting my eyes makes them very dry and then painful. It's always there and never goes away, it's permanent. I use drops all the time and have all four punctal plugs, plugged but they're still dry. When the headaches come it's disabling and interferes in my life. I just find it hard going on with a normal life with this dry eye disease, it never goes away. If i would have known this would happen, i wouldn't have gotten lasik at all, i would be much happier with my glasses.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037813  

 

My mother had a lasik surgery. The doctor told her it was a successful procedure, but she has developed extreme dry eyes, lost vision and her life is in complete disaster. She has not been able to work since due to the condition in her eyes. The doctor says her eyes are ok, giving the impression she is exagerating the symptoms. She was not informed correctly prior to the operation, but now it's too late for her. She is a dentist and had to close her office. We hope this doesn't happen to more people.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037814  

 

On the date of the procedure, after correcting my right eye without event, i experienced a "button hole" cut on left eye during lasik surgery, due to what i was told was an "equipment malfunction. " the procedure was stopped and i went home to heal. The procedure was repeated on the left eye 6 months later; however, that eye has never focused well again - (near or far) - and is susceptible to blurriness and irritation. In addition, night vision is diminished.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037816  

 

I had lasik eye surgery, and now my vision has regressed to a significant point - left dist. 20/25, right dist. 20/30 - and my optometrist warns me against attempting corrective surgery again. She claims my cornea is already too flat and if i sought surgery again it could have very negative effects on my vision, such as having a "fun-house mirror effect" where i would never see normally again. When i received my surgery, debris was caught in my left eye and i had to go back two weeks later to have it removed. The surgeons had to once again cut into my eye to lift a flap and clear the debris. The contract stated that i could get lifetime correction if needed if i sent yearly eye exams to them. My mother did this, but when i called the surgeon's office i was told they didn't have any of the faxed exams on file and i would have to bring them copies. Dates of use: 2003. Diagnosis or reason for use: poor eye sight.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037817  

 

I had lasik laser eye surgery. When the procedure was being done, the flap that was cut on my left eye was very thin. Then, the computer on the laser machine crashed. It took a few minutes to re-boot. While re-booting, the doctor tried to keep my eye saturated with fluids. However, when the very thin flap was replaced, it had a wrinkle in it. The wrinkle caused blurry vision in a starry pattern. I had a second surgery done to smooth out the wrinkle, and it helped, but the vision in that eye will always be a bit blurry. Also, an overall consequence of lasik that i was not adequately informed of before the surgery is dry eyes. It is especially difficult overnight, and especially if i've had a alcohol to drink before going to bed. I can detect a drying of eyes after just one glass of wine. Sometimes my eyes get so dry overnight that i wake up with incredible stinging eyes in the middle of the night. I keep drops on my nightstand so that i can immediately put drops in my eyes when i wake up. I reach for the drops with my eyes closed.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037819  

 

I was treated for vision correction using lasik. My vision improved from 20/400 to 20/25 and 20/30. I still wear glasses all the time to achieve 20/20 in both eyes. My main problems are starbursts around car headlights and other bright objects. Car headlights bother me even on bright sunny days. My night vision has been greatly reduced and my eyes are dry all the time. My dr. Explained the potential complications but these seemed to occur at a very low rate and surely wouldn't happen to me.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037820  

 

Prk surgery to both eyes performed to correct astigmatism and near-sighted vision. Prior hx of auto-immune problems, fibromyalgia, sjogrens syndrome, rosacea, osteoporosis, celiac, year-round allergies, treated with elestat, allegra, flonase. After prk surgery, dry-eye syndrome and blepharitis has persisted, despite treatment with restasis qid since 2006, warm compress and topical over the counter eye drops. Recent treatment with doxycycline 100 mg bid blepharitis and rosacea, with good results, but not resolution. Also continued low light issues, with loss of resolution. Starbursts and halos resolved after about 8 months with ability to drive at night and for more than 2 hours at a time. Md was aware of the above diagnosis except sjogrens, but apparently did not read the chart prior to surgery and did not advise the pt of dry eye possibility. Vision and dry eye symptoms are variable, depending on level of allergy reactions, humidity/dryness of air, fatigue and amount of vision use especially computer viewing. Pt is currently treated with restatis tid, over the counter lubricating drops prn, doxycycline 100 mg bid, warm compresses to the eyes qd.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037821  

 

Lasik surgery didn't work out. I was over-corrected from near-sighted to severely far sighted. "correction" procedure was performed four months later with little improvement. Now i have to wear corrective lens and get used to completely the opposite problem i had before lasik.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037822  

 

Bad lasik. Unlike many others, i read everything my doctor gave me and much on the web. I was ready for the halos and starburst, but hopeful that they would not occur. Not only did i get the halos and starburst, but i also had two others, and one far worse problem that was never disclosed to me by my doctor. Lasik also can cause your near vision to become worse. Immediately after the surgery i needed my reading glasses. When i asked my doctor, he indicated, "oh yes, that sometimes happens" and explained the reason why. Would have been nice to know before the surgery. Far worse was a severe increase in floaters in one eye again never reported. It is so bad that i literally cannot see out of that eye at certain times, and even in the best of cases, it's like someone put a piece of wax paper in front of that eye. My surgeon was widely known and highly regarded even appearing on abc's 20/20 as a fixit of other peoples problems, and he turned out to be a charlatan. Dates of use: 2002. Diagnosis or reason for use: see better.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037823  

 

In 1999, i had corneal tear when cutting the "flap" during the lasik procedure. After the full procedure, i had extreme star-burst images and full double images. These persisted for about 3 years when they started to decrease in severity. I eventually needed a prescription for trifocal glasses to correct the faulty vision. I still have a minor to moderate star-bursts and some double imaging. The doctor who performed the lasik procedure finally dropped me from his care. He didn't want me interacting with the other pts about my bad lasik experience. I have recently been diagnosed in 2008 - as having chronic corneal erosion syndrome caused by the lasik procedure.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037824  

 

After lasik surgery, i now have very poor night vision and will most likely have to stop driving at night within the next few years. I see halos and star bursts. It appears after some digging and research on my own, i have unusually large pupil such that the lasik cut/treatment area was smaller than the pupil. So during the day and bright light the pupil contracts to a smaller size, and is within the treated area and my vision is o. K. It's not 20/20, but closer to 20/30 or 20/35. However as it gets darker or cloudy, my pupil expands and the outer part of the pupil goes outside of the treated area and my vision gets worse. Then in total darkness at night a larger portion of my pupil is outside of the treated area, causing the halos and star bursts. Sometimes it's so bad that i have to turn on the inside car light to help shrink my pupil and to shrink the star bursts. Knowing what i know now, my doctor should have told me that this would be a side effect of having a large pupil. There is a good chance that knowing this and the severe outcome, i might not have had the procedure.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037825  

 

Lasik procedure resulted in the following problems. I was extremely nearsighted -something like 20/1000- with very thick glasses and somewhat dry eyes to start with. So dry, that i have difficulty with contact lenses. I sought the lasik because the weight of the glasses was putting constant pressure on my sinus, and i was in discomfort most of the time. Correction to 20/20 in one eye and 20/40 in the other did not work for me. Dr should have tested me with glasses first. So had to have a second procedure within a few months to change the 20/40 eye to 20/20. Double vision in right eye and a huge "flare" in that eye as well -- if i looked at a stop light at night, there was huge flare of light running off the top of the round light. This required a third lasik procedure a year later -- different dr and another $4,000. Both problems were substantially improved. Extreme dry eye - needed to use refresh tears every 10 to 15 minutes. Could barely open my eye in the am. Ongoing problems. Extreme dry eye has improved with restasis rx, which i expect to be using forever. Still also use refresh tears frequently. Blurry vision - mostly related to dryness. Night glare - with newer headlights coming at me, limits night driving. I have developed a cataract in the eye that was lasik'd three times. Not blaming the lasik for this, but current dr is very hesitant to treat the cataract due to the thinness of remaining cornea -?- material. A newer version of lasik machine was available at the time of my procedure. The dr did not inform me of that fact. From what i have learned much of my problem would not have happened with the newer machine.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037826  

 

I had lasik surgery in 2000. My vision before surgery was considered legally blind. I wore contacts prior to the surgery but my dr said that because of eye infections, i would go blind if i continued wearing contacts. I decided to get the lasik procedure. I was the 95th person my dr had performed the surgery in his facility. I was given valium before the surgery which made me jittery and made my palms sweat - the opposite reaction they were expecting. The surgery went well and the first couple of post-operative visits were fine, just a little blurry. Within a few days, i had a blurry spot where i could not see in my right eye. If i turned my head sometimes i could see fine from that eye. Anyway, after weeks of appointment, steroids and consultations with other physicians, it was determined that i had oil -sweat- under my flap. It eventually cleared up. I have had major halos at night. Oncoming traffic from a distance appears as large firework burts. When traffic approaches, my eye contracts and my vision is better. When i walk in the dark outside, small lights appear huge, such as doorbell lights seem big when i'm walking down the street. I have been told i have huge pupils. My present ophthalmologist says i have the largest pupils she has ever seen. My night vision is the pits. I see large fireworks. In addition, i was now told that when the lasik physician performed the surgery, he did not make my left eye my dominate distance eye. I am left-handed. I now have cataracts which were diagnosed. I was told that the operative site for the lasik is smaller than the area my eye dilates and that the blurriness comes when my eyes dilate, at night and i'm seeing my old vision on the outside of my pupil. Before my surgery, i wore a -9 in contact lenses. I do see lots better than i did without glasses but the night vision problems are permanent, and i usually avoid most night driving. I have some new driving glasses which helps a little bit, mostly because they bring my left eye event with my right eye or make my left eye more dominant.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037830  

 

Lasik surgery: extreme dryness both eyes after surgery. Quality of life impaired. Therapy continues: restasis, warm compresses on eyes, systane, doxycycline.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037831  

 

I was told i was a candidate for lasik surgery - did not inform myself well enough - took my doctor's recommendation and had it done. I suffer daily, wake up in the middle of the night - can't hardly open my eyes. Its acutely painful. I go through bottles of artificial tears as drinking water. Many, many regrets.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037832  

 

In 2000, i elected to have lasik surgery performed. The surgeon had difficulty with the equipment used to stabilize the eye before surgery, making multiple attempts at 'suctioning' the eye until it was bruised and bloodshot. Since i was approximately the 40th person to have lasik surgery performed by this doctor and on the same machine as all previous patients, it may not have been working correctly. What ultimately happened was that my right eye was 'corrected' to 20/20 vision, my left eye, however, was 'over-corrected'. Instead now of being near-sighted in my left eye, following the procedure, i was now far-sighted to approximately 20/40. This has made for difficulty in focus, especially at night. I generally see a double image of any light at night, stars, the moon, headlights, street lights, etc. All have a slightly off-set double image which is irritating to say the least. The surgery also decreased my night vision ability with the common side effect of 'starbursts' around any light source; headlights, street lights, traffic signals, etc. Over the years, the night vision has improved slightly as my eyes have healed. The double-vision though, has remained the same. When i told the lasik surgery clinic that i was having the double vision problems, they examined my eyes. They told me that the damage was not bad enough for it to warrant a corrective surgery and that i would have to live with the problem. All in all the experience was disappointing and painful. Had i to do it over again, i would certainly choose a different surgery clinic and would do much more research into the process before having it done.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037833  

 

Almost immediately after having lasik surgery, i began to experience chronic dry-eye. I used several different types of otc and prescription eyedrops, such as restasis, thera-tears and systane, which i still use daily. One to two years following the surgery, the "floaters" in my left eye became more pronounced and bothersome; my right eye soon began to show the same symptoms. It became uncomfortable to watch tv, especially in a darkened room. I was often unable to clear my vision. I was constantly blinking and shaking my head to bring my eyes into focus. My vision would clear for a second or two, only to cloud up again almost immediately. This condition continued to worsen over the next 3 years, to the point where i have pronounced difficulty watching tv, watching movies or live shows such as plays or concerts, and driving at night. In addition to the problems with focus and floaters, i also have worsening problems with the "starburst" effects; when there are lights in my field of vision they seem to be flaring and amorphous. Even very small lights are like un-focused headlights past which i often cannot see. This is especially the case when the light source is at a distance of 6 feet or more.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037834  

 

I had lasik surgery in 2007. For 4-5 months after the surgery, my eyes were very dry and i had to apply wetting drops several times a day. Also, my vision for the first few hours after i am up in the morning is not consistently clear. It is somewhat blurry and unfocused. This may be due to having gained a tolerance to the dryness. It gets better as the day progresses. I am assuming that the increased frequency of blinking is keeping my eyes wetter thus the improving conditions throughout the day. Now, more than a year later, my eyes always feel as if i have just woken up or been in a very dusty place. My colleagues often ask if i have an allergy or if i got enough sleep the night before.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037835  

 

Dr. Performed lasik eye surgery on me. The date above is estimated. I would have to go investigate to get the actual date. My eyes were not too bad (20/50) and i was told i was a great candidate for the surgery. I was concerned about the halos, but was reassured that my chances were extremely slim. I had the surgery and have had bothersome halos ever since. At night, the glares are bad and if it rains on top of it, it makes driving more difficult. Several years later, i heard there is a surgery to correct the halos. I called dr. And asked the question and was told that it would cost substantial amount per eye to correct the situation.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037836  

 

Since having lasik in 2005, i have had persistent severe dry eyes, trouble seeing at night, decreased depth perception, and sensitivity to sunlight. Also my vision has deteriorated to 20/50. Custom lasik, 2005 - not sure what day in - i received the lasik. Date of use: 2005.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037838  

 

I had lasik surgery on both eyes, to correct nearsightedness. Since the surgery, i experience visual distortions, such as halos, starbursting, glare, difficulty seeing clearly in most lighting-situations, except outdoors during the daytime (natural sunlight). There is also some dry eye, which was present, to a lesser degree, before the surgery. After the surgery, other optometrists (not the doctors involved in the surgery) told me that i should never have been considered as a candidate for lasik, due to my large pupils and existing dry eyes. My tbu is somewhere around 3-4; prior to the surgery, i was having trouble wearing contact lenses because of this dryness; i was told that lasik could help, as i would not need cls after the surgery. Ironically, the only thing that restores part of my night vision is rigid gas permeable lenses, which have to be fit by an expert. They are extremely difficult to tolerate and expensive. It is also extremely difficult to find a doctor with the experience for fitting contact lenses for these types of problems. It is also possible that equipment -malfunction may have occurred, as well. I have decentered ablations. In any case, my large 8mm pupils/dry eyes practically guaranteed that i would have the above mentioned aberrations. Any possible contraindications were downplayed. Pre-op, i had a definite intolerance to rgps -and even soft lenses. Lasik induces tear-film problems that exacerbate contact-lens intolerance. After years of struggling with soft contact lenses, i would never have risked being rendered dependent on a type of lens that i myself knew -and was known by doctors- that i was unable to wear. I believe that the initial fda study suffered from "under-reporting". That is, most people do not even know of this form. I, myself, only happened upon it by mere chance. I guarantee that there are far more than the "140" people suffering from life-changing lasik-induced problems. Again, i'm not sure what is being looked for. "therapy" would be theratears eyedrops to treat dry eye, and endless fittings for speciality contact lens -macrolenses, etc. This has been ongoing since 2000.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037839  

 

I had lasik surgery sometime in 2001. I am not sure of the exact date. I was extremely near-sighted prior to the surgery. My prescription was -9. 5 in my right eye and -9. 0 in my left eye. I started wearing glassed in approx. 5th grade, and contacts in 6th grade. I was very athletic my whole life and i hated to wear glasses, and so wore contacts all the time except for right before bedtime when i removed my contacts to go to bed -and i needed to wear my glasses literally, to find my way to the bed, the bathroom, etc. I was unable to see the clock by my bedside, unable to see a person's facial features a foot in front of me. I was very comfortable wearing contacts and they never ever bothered me one bit -beside the fact that you had to put them in and take them out everyday, buy solution, etc. So that is the background. I decided to get lasik. My father had successful rk in the late 1990's. Two of my sisters and a brother had successful lasik in the year or two prior to my lasik. I decided, why not me? it worked for them. I come from a family of 11 and we are practically all near-sighted to some degree, pretty severely in 4 or 5 of us. Upon my consult w/ the lasik doctor, he tested my cornea and said that it was probably thick enough to do the surgery, but wasn't sure it would be 100% successful, due to my severe prescription. I asked him if an unsuccessful surgery meant that i would not be able to see 20/20, but no worse off than my current condition at the time. He agreed and said, i would be no worse off. I verified that if the surgery did not work, i would still be able to wear contacts as opposed to glasses. He assured me i would. So basically, i figured, if the surgery was unsuccessful, all i would lose -or whatever it was at the time- and be right back to square one. Better than losing my eyesight. The surgery happened, and i definitely saw some improvement, i. E. I didn't have to wear my glasses/contacts to walk around the house or see the clock. However, i would consider the surgery unsuccessful. My night-vision was, and still is awful. And driving at night in the rain, forget it! i couldn't see the lines on the road, had a very severe depth perception problem, as in how close or far away is that car in front of me?, and the headlights on cars coming toward me were like big huge starbursts. I could not tell the difference sometimes between oncoming car headlights, street lights from above, and tail lights - at least these are red, so that clued me in. They all just looked like huge, huge circles of light. I had about 4 enhancements on my right eye in the next two years approx. , but to no avail. I actually developed astigmatism, my regular eye doctor told me, which i had not had previous to lasik. To make a long story short, i wear a contact in one eye, that eye is very dry, especially in air conditioning or direct heat - aka blowing from a car heater, and i don't see nearly as good as i did with my contacts pre-lasik. I wish i never would have gotten the surgery. I advise anyone w/ sight as bad as mine not to get lasik. Now, the shape of my eye -cornea- has changed so much from all of the enhancements that no contact will fit comfortably on my eye. I've tried about 5 or 6 different makes and models, even gave up at one point and wore glasses. I was furious and very sad, broke down in tears on many occasions. My eye doctor found this contact that works the best for me for now. As i said my eye is dry, but i will continue to wear it until i cannot stand it. There may come a time when glasses will outweigh dry eye. As for my left eye, i do not wear a contact. However, it is not 20/20. Can get along with it with the help of my contact-dependent right eye. I think it is actually far-sighted now -caused by the surgery. So there is really nothing i can do about that eye.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037840  

 

Lasik surgery left me with serious night vision problems, halo effect and dry eyes.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037841  

 

Had lasik surgery performed on both eyes. Serious "dry eye" has followed with pain in either or both eyes upon wakening. The original doctor indicated severe corneal erosion and prescribed various eye drops and salves along with contact lens bandages. These are not working. Tear duct plugs are in lower ducts.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037843  

 

Since having lasik several years ago, i have been experiencing episodes of iritis. I had never had these before. A medical work up was negative except for a positive hla-b27. Is this a side effect? is this something only those predisposed -say, being hla-b27 - get?

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037844  

 

My eye sight is now ruined thanks to eye center. I have had multiple procedures on both eyes because my surgeon was careless during the initial lasik surgery. He performed too many surgeries on patients during too short of time that day - the nurse said it was the most they had ever scheduled, 21-, thus rushing and not cleaning up the epithelium under my lenses. As a result, the epithelium grew lifting the lenses and distorting the eye sight. They also contaminated the right eye with a foreign contaminate. I suspect the right eye sight was worse because the assistant failed to keep it adequately wet during the procedure. I could smell and hear the burning of the tissue and eventually the surgeon told him to apply more liquid during the initial surgery. I called them the next day and said that something was wrong because i couldn't see much out of my right eye, and my sight in the left eye which had been ideal had now become blurry. They tried to convince me that nothing was wrong and they attempted to make me feel as if i was being unreasonable. After arguing with the center's optometrist for one month, they finally agreed to re-do the right eye after 3 months from the original surgery. Unfortunately, when they performed the second surgery, they over-corrected the sight and now it is impossible for me to read with that eye, and is sometimes blurry at a distance. Although the left eye continues to be somewhat blurry, i am afraid to have them re-do it for fear they completely screw-up the sight in it as well. They also left a great deal of cells that float around in both eyes, the right having more than the left which is extremely irritating. Furthermore, i have severe halos in both eyes at night. Now i find it difficult to read - they said they would sell me reading glasses, one eye is blurry, the other eye was over-corrected. I can't drive at night without putting drops in my eyes, and suffer from eye strain -pain- and headaches. What can i do now that my eye sight is ruined? they never warned me about any of this! the fda should have been proactive at the inception of the lasik surgical procedure rather than reactive, which is always the norm. Now that the damage has been done to thousands of people why is the fda not allowing the victims to receive compensation from the doctors? an insurance fund should be set up. It is virtually impossible to sue the surgeons since no other surgeon will testify against their own, and patients are required to sign their life away to have the procedure performed without honestly knowing the risks. For the people who have already had the procedure, we need more help rather than just warnings! help us!!!!!.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037846  

 

I developed salzmann's nodules in both eyes after having lasik surgery. I later had to have a second surgery to remove the worst of the nodules from my left eye. Some of them came back. I have them in both eyes and they run right along the periphery of the "flap" on each eye. My doctor tells me he has found no other cases where salzmann's was ever related to lasik although it's clear mine certainly is. In addition to the additional surgery, which was very painful, i have to use restasis drops every day. They are very expensive. It can be very uncomfortable particularly during the winter when my eyes get drier. At night my vision is very poor. Lights seem ot have halos or starbursts. Things look like they did when my vision was not corrected.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037847  

 

I had lasik surgery on both of my eyes in 2008. I now suffer from blurred vision and have a halo effect during the evening hours. I am not pleased with my lasik surgery. If i can participate in any surveys, or supply any additional info, let me know.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037848  

 

Lasik complications, requiring multiple attempts at correction with prolonged inflammation in recovery as a result of procedures. Lasik plus surgery centers.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037849  

 

Far sighted vision change in left eye. Near sighted vision severely worsened in both eyes. Dry eyes, esp left eye. Cannot wear contacts because of dryness.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037850  

 

Lasik eye surgery with the following adverse effects: severe "halos" and sensitivity to light sources, reduced night vision and driving ability, extreme dry eyes, slight vision blurriness/nearsightedness not completely corrected.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037851  

 

Lasik surgery gone wrong. Blurry vision, double vision, worst vision than before surgery. Pain, inflammation, redness, itchy, scratchy eye. Three months of pain. Twelve months of double vision and blurry vision.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037852  

 

Lasik patient. I had 20/20 vision after the procedure but my vision has grown progressively worse since then. I require reading glasses for close which i understand is a natural aging result that can not be stopped. But now my distance vision is actually getting worse. In addition i have dry eyes that makes my vision less than acceptable. I'll soon resort back to glasses or contacts i expected my long term satisfaction to be more long term than 7 years.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037853  

 

I continue to have problems with my night vision after lasik surgery. I still see starbursts and halos around lights that make everything look glary, which makes it hard to drive. Also, at times in the day i see some dark flutters at the top of my vision. When i told the doctor about it, but he said the flutters aren't related to the lasik, but i had never experienced this before. Also, he said the glare may be cause by the fact that one eye is corrected for close vision, and the other is corrected for distance. I had consented to this. I'm not sure these reasons are true.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037855  

 

Lasik - simple myopia. Vision was 20/35 at first - then deteriorated. Dr did a follow-up enhancement with same results. Now i wear contacts with a 2. 25 correction. Dr was leader in field told me that he did nothing wrong and i was a "bad healer".

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037857  

 

I had lasik surgery about 1 year ago. I opted for the laser, rather than the doctor, to make the cuts. For a couple of months after my surgery, i had very painful dry eyes. It was painful to open my eyes after a night's sleep. My doctor prescribed various eye drops, but nothing really worked until i received a prescription for restasis. In my opinion, restasis should have been prescribed on the day i received the lasik surgery. On a daily basis i still suffer from dry eyes, but nothing as painful as before the restasis. Now, i use otc bausch&lomb soothe drops when i wake up in the morning and throughout the day. Other than dry eyes i haven't had any other problems.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037858  

 

Lasik performed. Cornea epithelium did not heal well, would not attach correction fluctuated for months with lots of glare problems at night, but went from about 20/5000 to 20/200.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037859  

 

Lasik vision correction resulted in poor night vision and haloing.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037863  

 

In late 1998 and early 1999, i had lasik vision correction od and os. It was noted, but never disclosed to me that my corneal thickness was "borderline" and that i had signs of keratoconus in one eye. Within a few years after surgery, my vision deteriorated in both eyes - i wear contact lenses to correct my vision and it is barely legal for me to drive. My eyes are cloudy most of the time, very red and at night, i can barely see to drive. I see halos around all lights, oncoming cars, brake lights, headlights, street lights. Watching the television is difficult too. Everything in my life has been affected by this surgery!!!! due to what has been diagnosed as post lasik ectasia by several doctors, my vision fluctuates, i have extremely dry eyes. I am partially disabled because i can not fulfill the duties of my jobs which include driving, seeing, shooting guns, spending hours on computers and keen visual acuity. I have had to take time off to see doctors from one state to another. I have to take time to rest my eyes every day. I have spent money on physicians -7 of them-, medical supplies. I have a box of data and files and all laboratory tests and data and am willing to travel anywhere to bring them to you or send them to you. Please contact me immediately.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039142  

 

We didn't wish to get involved with the on-line form, so we are writing a letter instead. We are very interested in receiving info from your recent hearings dealing with lasik surgery. My wife is a victim of this horrible procedure. Six years ago, she underwent lasik surgery on both eyes. The results were no help with vision and ongoing pian in her right eye. We consulted with the top ophthalmologists regarding treatment for this excruciating pain with no help. Basically, the answers were "we don't know what to do to relieve your condition. " we ended up going to another state to see a dr, who we located thru the internet. His diagnosis was basically dry eyes and unequal distribution of tears over the surface of the eye. He recommended resurfacing the eye with placenta material at a cost for his fee and outpatient fee at the hosp. This procedure had very positive results and alleviated the pain, but it didn't last. The pain came back in 3-4 months. We are now back to square one with intense pain. Please send us minutes of these hearings or any reports derived form the hearings as prescribed by the freedom of info act. Thank you.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1212031  

 

I had lasik eye surgery on both eyes. I was at -3 diopter with slight astigmatism in both eyes before the surgery. I was near sighted. Before the surgery and during the surgery, i was not given any instruction on what to do with my eyes. The night before i read in the prep booklet that i was supposed to focus on the light. Following this direction i focused on the light during the surgery for my right eye, but when it came to my left eye, i had trouble focusing on the light, so i moved my eye to re-focus, and after the second time of doing this, the doctor finally directed me to stop moving my eye. Anyway, after the surgery, my left eye felt strange right away, like it was irritated more than the right eye and the vision wasn't as good. With the post-op care i told my doctors that my left eye was always irritated, but they couldn't tell what was wrong with it, only agree that it appeared to be more irritated than the right. It's a year and a half later and my left eye still feels the same pretty much all the time, like there's something in the eye, like i'm wearing a contact that should have been taken out a long time ago. The vision out of that eye is somewhat fuzzy as well. My doctors say that the only problem they see is that my eyes are drier now; about 6 second tear break-up time. They say that the irritation could be caused by sensitivity to dust, wind, particles in the air that wouldn't have irritated the eye before with a healthy tear film, but now do, because of the dry eyes. And this doesn't explain why the left eye feels so irritated and has poorer vision than the right, even though the dry eye is the same in both. When first dealing with this condition, i believe i had ptsd because i had suicidal ideations and had serious plans to kill myself of three separate occasions. I've had depression before, but never suicidal thoughts. This was shocking and a horrible experience. I am grateful to vision surgery rehab. I talked on the phone and email and shared my fears and my emotional distress and i finally came out of my suicidal ideation phase. Dr was helpful in giving me eye health info. Lasik center.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1211624  

 

Following a prk procedure, the doctor reported observing a "central island" in the patient's left eye.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1222366  

 

Reporter states that since his lasik eye surgery in 2005 that he has not been able to clearly see items that are less than 10 feet away. Repoter states that during the consultations with the referenced md, he was told that people with eye worse that his had been corrected. Repoter states that since the surgery he consulted with another md and states, he was told that he was not a good candidate for lasik surgery due to his age and the poor condition of his eyes. Reporter states that he does not know if the problem he is now having is with his eyes is due to poor surgical technique by the md, if there was a malfunction with the laser or if it was just because he was a poor candidate for the procedure.

 


Feb. 20th, 2010:
Dear Dean:

It is miserable to see your life defined by this ordeal.  While procedures like LASIK have statistical evidence of effectiveness, a small number of dissatisfied patients over time becomes an army. 

We live in a different world now.  Many years ago you could have a collection of baseball cards that was worth quite a bit of money.  But once the internet arrived, everybody posted their b-ball card collection online and their collection became worth less because of knowledge of the large supply of cards available.  In the same manner, LASIK is now performed in a fish bowl.  Now everyone can learn of the downsides of LASIK in human terms, not scientific studies.  There are unseen dynamics here... the more you complain and seek legal recourse, the less interested other eye surgeons are in helping you.  Professional jealousy also left Dr. Caro to handle his complications by himself.  Good doctors refer their problematic cases to local university centers.  Obviously, Dr. Caro was hiding his bad cases from the view of his colleagues.  The cornea scan you show on your eyes is one of the most miserable I have seen.  In legal terms, a poor outcome does not equate with malpractice.  So a doctor with poor outcomes can continue in practice.  The problem is, the LASIK surgeon must build a reputation for himself and must brag of his results (imagined in some instances). The ego problem gets in the way.  So does the money, millions of dollars here.  The dry eye issue is simply pushed aside as an annoyance, while the ability to read the eye chart is the measure of success.  The data the FDA received was largely visual, based upon a test performed at a fixed time, not the entire visual experience.  If you can see the eye chart better but your eyes are itching, burning, tearing, blinking all day, what is that?  A poor outcome, that is what it is.  The tear film is produced by glands in the eyelids and often eye doctors don't recognize the importance of vitamin A to produce mucin, essential GLA oils (borage, evening primrose, black currant seed) to produce the oily layer of the tear film.  You are correct in stating the corneal nerves must signal the eye to blink and coat the surface with tear film.  It would be interesting to see what a molecule like resveratrol would do to further stimulate healing in your eyes.  This molecule inhibits abnormal growth of nerves and blood vessels in some tissues, but stimulates them to promote healing in other tissues.  I hope God provides you a different "focus point" in your life.  What the FDA wouldn't do, the economy has done -- put the LASIK sharks out of business.  -Dr. XXXXX


Dear xxxxxx,

Thanks for taking the time to speak with me today and I'm following up our conversation with a brief synopsis of my problems after Lasik surgery in May of 2009...

 

I was having trouble reading and using my computer at the age of about 43, I'm 48 now by the way and the problem became worse requiring me to constantly change to reading glasses throughout the day. I'm a reserve Deputy Sheriff and work full-time for AT&T so I'm in the field all day and every day and changing from Sun glasses to reading glasses started to become quite problematic. WOW what I would do to have those problems back after the absolute devastation to my life after being assured that the glasses would go and no contacts ever by my Lasik Doctor and her staff.

 

I was treated for Mono-vision by the Lasik Dr. and found out later that she should have tried contacts or glasses first before performing the lasik mono-vision correction which has completely ruined my life. The last 9 months of my life has been pure hell and nightmares.

 

I'm currently suffering from extreme dry-eye, red-eye, painful-eye, lost vision up close, lost vision at night and extreme sensitivity to sun light after I was assured how safe the procedure was and I was told their track record was perfect by the Dr.and her staff and I would be without glasses or contacts. This sure seemed like a great thing especially after reading all the wonderful lasik info (on-line) that I researched before going forward with the procedure. I'm sure no one chooses to get lasik to distroy there vision and comfort but thats what happened to me and now I'm suffering badly every day and need help.

 

My life as a respected Police officer and my hobbies of Fishing,Scuba diving,surfing,working out at the gym,bicycling and living my life happily are now over and its been all Doom and Gloom for me and I have even considered suicide but a very close and loving friend has kept me from doing this.I would rather go blind and live in pain and anguish than to not see her again. At least thats what I feel today but I came very close a few different nights.

 

I've read your web-site and spoke to you and hope you can help me to bring my life back on track. I'm sickened and disturbed that lasik is continuing to go on in this country and apparntly the FDA doesnt have a clue.I wish I knew all the facts before hand but I didnt.  I went by what was on the Radio, TV, the internet, the information provided by the Lasik Dr.and her staff and now I'm really suffering. Boy what I would do for those reading glasses back!  Thank you for taking the time to listen....

 

 

Sincerely, James xxxxx


 





Feb. 1st, 2010

Dear Mr. Kantis, 

 

Thank you.

 

I can't tell you how relieved I was to find your website, hear your story, and realize that so many others have also had less than optimal outcomes from LASIK.  I thought with the stated 95% success rate that I was one of only an unlucky few experiencing these problems.  Although I'm very sorry that you too have suffered, as you know personally, it does help put perspective on a problem, when one know that one is not alone in a situation like this.

 

I will continue to study your website and links and will contact you as soon as I am able to develop some kind of objectivity about my situation.  Right now, I'm still gathering information about the general subject matter and my own situation, in order not to waste your time when I do have the chance to speak with you personally.

 

Thank you again for the information you have shared with other American citizens, and for the outspokenness and passion with which you have requested that the FDA perform the due diligence necessary to understand the true adverse event rate for LASIK, so that others will have complete and correct information about side effects, prior to their making such a critically important decision about their futures as is the case with LASIK.

 

I have always been respectful of the FDA, and I honor its important safety role in our system and government.  I've been in the fortunate position to have met and come to know several local, regional and other FDA directors in the area of biologics; I have had the opportunity to work with many FDA staff members who are knowledgeable, dedicated, caring, and who seek to do their jobs well every day.  I am hopeful that, in this case, the FDA will indeed fulfill its mission and obligation to protect the safety of the American people from potentially harmful medical devices and simply dig in and find out and publish the true side effect profile of the LASIK procedure.

 

Thanks again, so very much, for your hard work on behalf of those of us who have been permanently damaged by LASIK.

 

Best regards,

 xxxxxxxxxx


May 22nd, 2009:

Dean:

I wanted you to know, that your work, on behalf of all damaged, destroyed by LASIK---the lies, the subterfuge, fraud, ----------your work has been extraordinary in the face of all that you, yourself have had taken from you by this barbarous chapter in medical history.

It resembles so much the era of Nazi Germany--so many people who said, "they didn't know"---

In this case, it is some of the doctors who finally are coming to the fore and saying "they didn't know"----but they did. 

Let every one of them who have embraced LASIK, have it performed on them----let them pay for what they so dearly embraced----their enhanced income, health of the patient be damned.

Shameful.  Disgraceful----,the actions or rather inactions of the FDA and entire Medical Community.

They have all the tears, and blood of those ruined careers, lives on their hands--and ultimately, on their heads.

Survivors of the Holocaust, echo, "Never forget"----

We should never let any of those who participated in this atrocity forget---a list should be compiled----and shared.

They should pay.  And they will.

The Bible says "an eye for an eye'----how appropriate. 
 


May 11th, 2009

Dean,

Thank you for taking the time to speak with me today and helping me through what is undoubtedly the most difficult experience of my life. Your advice on how to proceed, despite the setbacks we have suffered at the hands of those who we entrusted to better our lives, is invaluable and very much appreciated.

I very much want to take legal action against those whose greed has resulted in immeasurable pain to us, as well as many others close to us. Dr. Emil Chynn and his practice, Park Avenue Laser Vision, need to be held accountable for the debilitating effects their dishonesty and malpractice have had and will continue to have on my life. As advised, I will contact Todd to discuss this goal with him. 
,

xxxx


May 4th, 2009

Thank you for your kind response. How can I obtain my records? Should I
just ask my surgeon? Basically, I am struggling with intense
pain/pressure behind my eyes and along my brow line. I also have extreme
irritation, I have been on countless steroids and other drops (Restasis,
pataday, antibiotic ointment). They have said I have allergic
conjunctivitis and blepharitis but I can't imagine that would be causing
such pain in my eyes. I have been told that I have no refraction error
and I am seeing 20/15 but I have a constant headaches and I feel like my
eyes are straining to focus. My doctor thinks that I should be happy
with my results but I am miserable! I am a graduate student in the
process of writing my thesis, I also do a lot of microscope work.
Needless to say, the lasik complications are interfering with every
aspect of my life. The doctor also mentioned that I have a dry spot on
my cornea that he would like to "scratch" to initiate healing. Basically
give me an abrasion...I don't think he really has any answers and is
using the kitchen sink approach.

I am sorry to be so long winded but I can't seem to find any help.

Sincerely
xxxxxxx


May 1st, 2009

Atlanta Braves Catcher, Brian McCann's vision ruined from LASIK...He tried contacts and glasses, but may need further LASIK surgery.
http://www.ajc.com/sports/content/sports/stories/2009/05/01/brian_mccan_injury.html


April 30th, 2009

Dear Dr xxxxxxx,

   I'm an 18 years-old Asian who had custom-wavefront LASIK on 3/4/2009 in Vietnam. After the surgery, I experienced very noticeable starburst and halo that seemed to be unimproved after two months. I also notice my contrast sensitivity on my right eye is more than the left one. My pupil is about 4-5 mm (measured in light condition). I've asked my doctor but he was very impatient and didn't care about my problems He said that my condition would be improved in six months. I'm worry. Do I need an enhancement or not? Will the enhancement remove the starburst, halo and contrast sensitivity problems? Does the enhancement cause dry eye?
   I'm going to the US to study at 8/15/2009 in New Orleans. I was confused by both the information provided by LASIK company and LASIK complications website.  Where can I find the right doctor in Louisiana to resolve my problem?
   Thank you very much.


April 13th, 2009

Hello, 

My name is xxxxxxxxxxxxxx and I'm terrified mother of 24 year old son that just recently had a lasik surgery done on both eyes.  It was a Customvue Wavefront Intralasik done in Edmonton, Alberta Canada. Before the surgery his right eye was +3.5, the left eye which is a " lazy eye" was +3.25. This is a 6th day after the surgery and his right eye vision is same as before surgery, left is worse and both eyes are very blurry, so he can not see much from close or distance ( no computer, TV, driving, working). He is using his drops as prescribed, keeps his eyes closed as much as he can, but there is not even slight improvement. He is devastated and afraid that it will be another Lasik disaster. He called his doctor's office with his concerns, the assistant was surprised, but she looked at his record and told him that everything looks good. I do not know if what he is going trough is normal, but I do not have a great trust in the doctor either. He was not present during the initial consultation, he did not respond to my sons phone call, but his assistant. I would like to ask you on my sons behalf if it would be possible to schedule a consultation with you. He will fly to Florida at any time suitable for you. Thank you very much.
 


March 30th, 2009: 

My vision was also ruined by Dr. Nick Caro of Saint George Vision Center, Chicago, IL.  Thank You Dean, That Monster Damaged my eyes and my mothers eyes as well. I am familiar with the site because of mortgages business, but let me know what is that exact part of the website, That I can file the complaint. I too Suffered I drove from Detroit, Michigan, like I explained... me and my mother were tired of wearing glasses, 01-02-98. I remember the assistant Leo was performing the procedure Within the next 20 days must eye began to hurt, all I saw was a white cloud, for my in my left eye. I was scared we got in the car my stepfather we drove to Chicago as fast as we could non stop, it was  Sunday. we called his office it was an emergency, he waited till Monday, when it got worse negligence. I can remember Nicholas Caro said " it will be okay " of course I was scared senseless out of my mind. I could not sleep nightmares, also found the retina was detaching in the right I seen a retina specialist, he recommended doctor in Arlington heights did help, only thing good happened, 20 trips back in forth, he said go to cornea specialist. Till this day I have contained some type of inflammation above the sinus area above the left and side of my right ever since that excuse my French " freaking surgery " I was a young man, I had corneal transplant after in Michigan, living nightmare, you can gladly share this story. Whatever you need from my part, I am glad to help put this soulless monster from hurting anyone else, seems like the law protects the trash, I wondered if he was involved with the mafia. since the protected him like a bullet proof vest. I am also sorry for you Dean, I did not know so many people were against him, I had almost forgot about him, until 2 years ago I drove past that place and I was so angry old feelings. Bottom line " Justice needs to be done, I don't care about the money, but as long he loses his license does not hurt anyone and does not get rich off, someone's dreams with his false promises, and affects peoples lives and their families, My Godfather - Uncle Jose my mother brother said that is just you guys till 2 yrs ago , a doctor told him, that guy Caro is bad news in Spanish, he has so many lawsuits it is not funny...

Regards,

Gil
Chicago, IL


February 4th, 2009

Hi Dean,
 
I have to head out to work right now but hopefully I'll be able to talk to you sometime about the problems that I've been  having after Lasik. Some support in dealing with the decision I made to go through with Lasik surgery and advice on how to get better would be much appreciated. I'm in Canada.
 
I'm 8 weeks out of lasik and I'm not pleased at all with my decision thus far. After reading through the various different internet forums and articles after the fact I now realize that is was the most reckless decision I've made in my life. Especially since my correction was only a mild one. Figure it will be extremely hard to forgive myself.

Currently I'm in constant pain, it's the most annoying when I try to read or work on the computer but it never stops even when I sleep (enough so that it is seriously limiting the amount of sleep I get each night). From my latest visit with the clinic and a second optometrist it seems that my problems could be a combination of allergies, dry eye, and eye muscles and a brain trying to get use to my new eyes. We will see how it all progresses. I'm having a hard time making it through the day, not sure that the allergy drops are working, may have to go with the punctal plugs, feel like I'm having some serious dry eye when I work on the computer. Nose also burns along with the eyes. I'm pretty much shot after 2-3 hrs of computer work, I'll have to eventually tell my employer because I'm no longer functioning.

I do still have a slight astigmatism in the left eye, the right eye seems to be a lot more painful then the left. The right eye seems like it wants to stay wide open, while the left seems to be a little more relaxed. Not sure if the astigmatism could be responsible for my night pain, probably more related to the dry eye. After reading only a page or so from a book my eyes feel like those times I'd get caught up in a good book and stay up all night with it, exhausting.

I don't trust the technician's or doctors from the clinic that I went to and I'm not sure that I'll actually be able to find an eye doc that will be able to help.

,
xxxxxxxxxxxxx


January 20th, 2009

Most refractive eye surgeons put their financial portfolio concerns way ahead of any concerns for the well being of the patient. This is just another point that needs to get out to the general public. I personally cannot think of another medical profession where this occurs on such a widespread basis. We all know of cases where cosmetic surgeons (who were obviously incompetent) ignored their patients' concerns in order to further their financial gains. But, these cases are relatively infrequent.

When Lasik patients encounter great difficulties and problems, they are many times attacked for 'taking the risk' as if they were ever really informed of what they were getting into. This, to me, is the ultimate insult about Lasik, that patients are blamed for not knowing that they were lied to and the whole concept of refractive eye surgeries, as they exist today are only based on 'junk science' anyway. Lasik is Third World technology being used to destroy lives and make a few immoral bastards more wealthy than their meager talents would have ever been able to accomplish for themselves.


October 24th, 2008:
Prof. Lising’s wife blinded by botched LASIK

Lesley Michaels
News/Web Editor


Lissa Lising – wife of Ian Lising, assistant professor of speech communication – discovered just how wrong a regular medical procedure can go when she was rendered partially blind in her right eye following corrective vision surgery. Lissa Lising, an attorney, made the decision to seek the surgery at LASIK first in Hawthorne in Decem­ber, where she recalls being rushed through a large group of patients, eager to have the procedure before the holidays. Lising cites miscommunication and a hurried schedule of patients as reasons for why her surgery failed. “The doctor never explained to me what to expect from the procedure,” Lising said. The procedure is supposed to be done one individual eye at a time, separated by a few months for evaluation. Lising knew nothing of this policy, since her doctor performed on both eyes. Lising also recalls the Web site misleading clients into thinking it is a painless, safe and hassle-free procedure. Though Lising recalls signing a disclaimer, it mentioned nothing about machine malfunctions, which raised suspicions. According to Lising, a fail-safe stopper was not installed on the machine, which would prevent the needle from penetrating through more than one layer of her eye. When Lising was approached by the machine, she was unsure of what was happening and hunched over into the machine in nervousness, resulting in severe cornea damage. “If a patient is scared or unsure of what to do during a procedure, a responsible doctor should turn off the machine and consult the patient,” Lising said. According to Lising, the only words the doctor expressed to her upon seeing Lising’s pain was, “Oh shit,” not words Lising or any patient would be enthused to hear. A pt reports following lasik surgery, he is experiencing floaters, glare, halos, severe starbursts and dry eyes. The pt stated the floaters make it, 'difficult to see' and he is having trouble driving due to the starbursts. The pt wa seen by several drs for second opinions. One dr mentioned corneal imperfections and flat corneas. The pt indicated he had done some research and found out about central islands and thinks that is what the corneal irregularities are. This report is for the left eye, the right eye is being submitted under mfr # 1061857-2008-00081. The surgeon who performed the lasik procedure on this pt indicated the pt did not have central islands and has not been harmed or injured by this event. The surgeon declined to provide any pt records. Pt records were provided by one of the drs the pt saw for a second opinion. The records indicate at 4 mos post-op bcva in the right eye was 20/15; left eye was 20/15-2. Ucva in both eyes was 20/20. Pt has peripheral vascular disease.

 Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when add'l reportable info becomes available.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053952

 Initial lasik surgery performed in 2003. Two weeks after surgery, i experienced blurred vision & shooting pain in the left eye. From there i have five corrective surgeries. I've been to four different corneal transplant specialists. I am now facing a corneal transplant, but the only problem is that the cornea will be repaired but the pain from the nerve damage is irreparable due to numerous surgeries. Now my only relief is to apply ointment & tape a gauze bandage to it to get the eye toned for the following day. I struggle daily with side effects like constant eye pain & other overwhelming side effects. This has taken a toll on my emotions & quality of life. For me, not a day goes by without wondering how much worse the pain level can become with no medication for relief & also the future cost incurred by this can become an issue.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052127  

 Pt reports that she was not informed of the side effects of the prk surgery states that five hrs after her surgery, she experiences intense pain. She now has extreme dry eyes, has to close one eye to drive because of halos. Pt states that she has to wear glasses to see, however, the glasses makes her nauseated. The office where she had the surgery promised to send her a pair of glasses and has not as of yet.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053909  

 In 2003, i underwent lasik surgery using the ladar laser for severe hyperopia and astigmatism at the eye center. I was told i would at least be seeing 20/40 the next day, which was not the case. After going through several pairs of glasses and several months, my vision finally settled. I cannot, however, achieve 20/20 in my right eye anymore with glasses. I can't wear contacts because my eyes are too dry now, and i can't tolerate the hard lenses. I have had problems with halos and starbursts since surgery, and they continue now, 5 years later. I now also have a problem with some mild ghosting in my left eye with certain lights. I also lost contrast sensitivity as a result of the procedure. I do not drive at night unless necessary because the oncoming headlights obscure the road. I did not read and sign a consent form until after they had taken my glasses and given me ativan to calm me for the procedure. During the procedure, dr had a problem while using the laser on one of my eyes because i could not hold my eye still, apparently, and he kept telling me over and over to hold my eye still. Not so easy when he's yelling and i'm nervous as hell as a laser is burning off part of my eyeball. I just want others to know and understand the risks associated with lasik surgery and for these money-hungry doctors to be more open about the risks of this elective surgery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052128  

 Pt reports that after having laser/lasik surgery on both of her eyes, she can no longer see and this has caused her not to be able to obtain her driver's license.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052885  

 Patient had lasik surgery in 1999-?-. In 2006, noticeable decline in vision quality sudden began. In 2007, patient was seen again by surgeon. In 2008, patient was told he had cone shaped corneas and should be enrolled in the fda trial. No other recourse was offered. Research dept's packet strongly insinuated that the lasik was the cause of the now degrading eyesight. Patient requires glasses once again and vision is constantly changing.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052136  

 I have heard that the f. D. A. Is investigating lasik surgery and is interested in pts that have had unacceptable outcomes from lasik surgery. I had lasik surgery on both eyes approx ten yrs ago. Prior to surgery, i was extremely nearsighted. The surgery overcorrected my vision. In 1999, i went to another country for lasik to correct the now farsighted condition. I had surgery on my right eye at that time. The vision in my right eye is permanently distorted following that surgery. I was told that my condition was a "fluke" and they had no idea why my eye did not heal as expected. I now wear rigid contacts which corrects the irregular surface of my right eye and the farsightedness in my left. My uncorrected vision is improved from the original condition but not well enough to drive or do everyday tasks without contact lenses. The laser ctr.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052221  

 In 2001, i had lasik, first on one eye and then on the other eye one week later, at a clinic. I have struggled with dry eye ever since, ranging from mildly to severely annoying. Despite having tried punctal plugs, daily hot compresses, and doxycycline therapy, my meibomian glands have never returned to normal function. Of course, i have since learned this is considered a 'minor' lasik 'side effect', most likely due to the permanent nerve damage wrought by the microkeratome -hansatome- and excimer laser -visx- devices your agency has approved for medically unnecessary purposes. I observed my first floaters--signs of a posterior vitreous detachment--within weeks of the lasik surgery - reported september 2001. This i have learned is due to the high pressure caused by the suction ring used with the microkeratome, which your agency has approved for medically unnecessary purposes. I noticed double vision symptoms, especially at night, soon after the surgery. I was relieved in 2002 that i was able to get a prescription that seemed to relieve these symptoms. However, over the next several years, i went in for several more prescriptions, each proving a bit less satisfactory than the last. Finally, in 2007, i was diagnosed with post-lasik ectasia, as my corneal topographies showed the trademark sign of inferior steepening, which accounted for my increasing cylinder and increasing symptoms of double/multiple vision. I have thick corneas, had stable refraction for 2 years, and measurements of flap thickness with an artemis device showed no signs of a too-deep flap thickness. In other words, i was a 'perfect' candidate, whose preoperative topography -which showed ~0. 5 d of inferior steepening- would probably not be turned away today despite the new 'stricter' guidelines being suggested. The reality of course, is that nobody is a good candidate to have their corneal strength weakened by a third by a microkeratome, for no medically indicated purpose. However, this butchery remains approved by your agency. The reality is that keratoconus remains poorly understood. At this point, i'm still -barely- correctable to 20/20, so by some accounts i'm 'normal', despite the fact that one can see 20/20 -or 20/16- with significant irregular astigmatism that is anything but 'normal'. This has been known in the keratoconus literature for years. Yet your agency continues to employ outdated visual acuity measurements as the 'clinical outcome' measurement for approving devices. This is convenient for the doctors, especially so because '20/20' has been popularly misunderstood as 'perfect' vision, when it is anything but. In the last several years, i have read with interest about 'wavefront-guide' treatments, with an interest in reducing my irregular astigmatism. I have been shocked and appalled to see that devices marketed as being effective in reducing higher-order aberrations have actually shown no data to this effect, whatsoever. In fact, they merely reduce the amount of induced higher-order aberrations. They have reduced hoas in patients with initially high levels, but the reductions have been small. It's shocking that devices known to increase higher-order aberrations / on average/ are approved for general use. Should not people be warned that their hoas--their quality of vision--/ will/ be reduced? -though maybe not enough that they'll notice or care. Now i am considering a topography-guided ablation, as this is the only approach that has some track record of consistently reducing irregular astigmatism and hoas by significant amounts. Indeed, several doctors in another country have now several cases of improving forme fruste keratoconus patients' best-corrected vision. However, your agency has not seen fit to at least give humanitarian approval to the laser refractive surgery devices that /do/ have a record in reducing irregular astigmatism -e. G. The suite from ivis technologies and/or the topography-guided options from wavelight-, which is a legitimate medical purpose for refractive surgery. This of course would not be lasik, but rather surface ablation. It is unclear why lasik remains approved today despite the mounting evidence that surface ablation is much safer biomechanically. So i will have to leave this country, and visit europ instead, to have a chance to improve my vision and likely also do corneal collagen crosslinking, which was kept a well-hidden secret from us patients -frequently along with their ectasia/keratoconus condition itself, as doctors frequently don't diagnose what they can't effectively treat- for many years, by your agency. Ironically, i have been funded by the dhhs -nih- in the past, during my phd work. I work as an optical engineer, developing adaptive laser scanning systems for neuroscience research. I've developed a cutting edge system, and might well have moved towards consideration for future nih funding, including the pioneer award. Of course, now it's difficult to work in the dark, so my scientific career prospects are significantly diminished. I am able to work for now under private funding. So, do consider that your agency's behavior has not only been reckless, but counterproductive. I hope you're ashamed. Dates of use: 2001. Diagnosis or reason for use: good question! nominally a 'disease' called myopia.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052147   

Following lasik surgery, i have experienced severe dry eyes and fluctuating vision throughout the day as my intraocular pressure changes. My vision fluctuates between approx 20/60 - 20/120, requiring me to wear two different pairs of glasses depending on the time of day.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052148  

 The date of the "event" is the moment of realization of the problem, not the date the lasik occurred. I had lasik performed about 10 years ago by a dr. My vision was excellent immediately, but began deteriorating and i went in for a redo on one eye a little over a year later. My vision continued to decline and i learned, it was not correctable by glasses. I realized a few years ago that i was seeing triple, but didn't know why. I didn't put it together with lasik until 2007 surfing on the internet. The medical forum talked about a pt whose triplopia was caused by lasik. Then i met an optometrist who was familiar with triplopia. He examined me and confirmed he couldn't do anything. He suggested getting legal representation but i don't have the money to do so. He told me i will not be able to pass a dmv eye chart exam. I didn't think there was anything i could do. Then my daughter heard on npr that the fda is looking into lasik issues and that's how i got here.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052143  

 Lasik surgery on both eyes. Problems: evaluation for candidacy did not include a thorough explanation of the effects of substituting distance vision for close vision in an older person. I was told that i would probably need reading glasses. Before the surgery, i was able to take off my glasses -which i had worn for myopia since age 8- and see up close. I was able to read, to put on makeup, to cut my toe nails, to see faces up close, to work on the computer - in short, the vast majority of activities that one does. I could not drive without my glasses or see distances. As a result of the surgery, i could drive and see distances, but 99% of my daily activities were now no longer available to me without reading glasses. In addition, i could not see as well with the reading glasses. I wore progressive lenses before; i wear progressive lenses today. Eight years later, i am still angry and mourn the loss of my vision every day. The issue is whether i was an appropriate candidate for this surgery in the first place. 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776  

 I had lasik surgery in 2001; a year later, my vision had worsened, so i had to have it again; to this date; i cannot see anything without rigid gas permeable contact lens that i can only wear for 8 hours a day; i'm literally blind without these glasses; i only wish i'd never gotten this surgery, because glasses don't even work. I'm really sad and depressed about this.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078775  

 I had lasik surgery in 2002. In 2008, i was advised i could have lasik enhancements because my vision had changed. I now have moderate dry eye in one eye and extreme dry eye in the other. I also experience severe pain and discomfort when i try to read, watch tv, look at a computer screen, or anything that requires me to focus. My eye surgeon has placed a permanent plug in my tear duct. I use eye drops every 30 minutes and get very little relief. It has made my life miserable. I went to a cornea specialist last week. He suggested taking fish oil and other multiple vitamins in hopes of making my eye better. I was not explained the possible complications by my eye doctor, and if i signed a consent form, it was just the same day and just prior to the enhancement procedure. If i had known the possibility of the severe dry eye, i would have never had the procedure done. I am very upset with my doctor!!!.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1077192  

 In 2008, i underwent lasik on both eyes in the offices or dr. The next day my vision was very blurry and i went back to dr and was told that my flaps were too thin and that i would need an enhancement surgery, but this may not correct the problem. When i asked why this happened, i was told that, "it is just medicine" by dr. He also asked the equipment mfr why all the machines told us i was the "perfect candidate" for lasik and then this happened. They also had no response. I believe the maker of the equipment is nadik. So now i have gotten 3 second opinions and all agree that it may be fixable with add'l ptk surgery, a yr of treatments.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075511  

 

Lasik complication. Following a lasik procedure i developed inflammation and central toxic keratopathy -ctk- resulting in severe hazing across the cornea, arge straea, and a blistering of the epithelial layer. Betadine was administered even though i reported an allergy to it. Hazing cleared, but halos in day time reflections and night time lights are prevalent in both eyes. I am now 4 steps farsighted -was 3. 5 steps near sighted- in one eye. Irregular astigmatism persists causing ghost images and fuzzy vision. I believe this to be a permanent condition after nearly 2 years.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075441  

 The military used prk corrective laser eye surgery on both of my eyes, and my vision in my right eye has become blurry. I have difficulty reading emails on my laptop and cannot read the powerpoint presentations during class. At night, i see starbursts around lights which has made driving dangerous under these conditions.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073789  

 Starburst and night vision problems since lasik eye surgery. Starburst began immediately after surgery and never subsided. Vision seems to be getting worse. It was a rare family history of glaucoma. Lasic surgery tlc laser- whitten.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1074478  

 I had lasik eye surgery and have suffered numerous side effects in my vision. Including a loss of peripheral vision in both eyes, floaters, regions of depressed sensitivity in day light vision. Night vision has degraded significantly and my vision has a yellowish tint. In addition, i require daily eye drops for dryness and get flashing migraine headaches on occasions. I have extreme difficulty reading, and can not do technical work anymore. I deal with eye pain and eye strain daily. Additionally, my eyes are very sensitive to sunlight. Now i just go to college and live off the proceeds of my house. I am also registered with the learning disabilities center as visually impaired. Yet, my eye dr says my vision is 20/40 and i am fine. I still need eye drops for dryness 2. 5 years later. Additionally, i feel that my eye dr who did the lasik procedure is not being truthful with me and i have to pay for this checkups every six months for the rest of my life. I am getting ready to apply for disability.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075348  

 Post operative data of a pt treated with the wavescan revealed an over correction of +2. 00 diopter in the right eye and +3. 00 diopter in the left eye at one month following treatment. Pt also is experiencing dry eye. Patient's best corrected post operative visual acuity in both eyes is 20/20.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073784  

 Lasik eye surgery has caused me severe pain, damage and trauma. Every day of my life it consumes me. Every day, all day, my eyes are dry, sore and in severe pain. I use expensive eye drops and they only provide a split second of relief. It is painful to do my favorite activities, such as reading. It is painful to do my job as i work from a computer. I am scared to go swimming, to the beach, or snowboarding because they may only irritate my eyes further. I can not go outside without sunglasses. I no longer think i can go back to school because reading is so painful. It is painful to sleep and painful to wake up. All day i live in complete misery. I am only 24 and am sad every day because i realize my life has been ruined from this surgery. Today i saw someone wearing glasses and was wholly consumed with envy. I wish i could wake-up from this nightmare. I'm scared and have little hope. I don't want this to happen to others. Thank you for taking the time to read this.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069870  

 I underwent lasik surgery in late 2005. I have dry eye complications from that surgery. I heard through the news about the fda hearing today and was dismayed at the fact that only 140 complaints were made. I need to know what i should do to let the fda know about my complications. Please provide me with instructions. I am desperate to have the lasik industry changed to protect future pts. (as a side note, i was a healthcare admin for over 10 yrs, and before that a scientific researcher- so i was a little appalled hearing that less than 1% of lasik pts have complications- there is much research, websites, etc. That prove otherwise). Your advice and direction will be greatly appreciated.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069871  

 I was eger to share my experiences once i found out about this hearing. In 2000, i had lasik performed. In 2007, i began having sensations of sand in my eye or sometimes, when very dry, glass in my eye. It was very painful. I also had photophobia, and could not look at the computer screen (i need to use for my job) or the television screen without eye pain. Also, it was difficult to drive - in some cases, when i would administer eye drops when my eyes were dry, the drops would turn to almost a gluey consistency, and it was difficult to see - somewhat like looking through wax paper - not good for driving. This condition took over my life for the next yr, while i went from dr to dr in search of a solution to the pain and discomfort i was experiencing. Some drs said this condition could not be linked to lasik, because it didn't occur until 7 yrs post-lasik (interestingly, these drs also had lasik practices). However, 2 of the ophthalmologists i went to (including two drs of the eye center affiliated with tufts) did feel it was due to lasik. I now have the boston scleral lens and it has helped me tremendously.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069872  

 I don't know if the fda addressed the issue of inaccurate intraocular eye pressures and intraocular lens calculations in post refractive surgery pts but this had become a real problem. I am a board certified ophthalmologist (cornea specialist) who performs lasik and prk as well as cataract surgery. What most refractive surgeons omit telling pts is that refractive surgery changes the curvature and dynamics of the cornea. This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult. If the preoperative, operative and postoperative info is available, it can be used to better calculate the true intraocular pressure and implant power. Most refractive surgery pts are in their 20s and 30s but glaucoma and cataracts don't become problems for decades later. By this time the medical record is lost or unavailable. To help address this issue, i have started a web-based refractive surgery database where pts or their refractive surgeons can store this info for further use. The website also provides info for pts and contains an extensive list of references regarding this issue. Whether pts use this database or not it is important that they obtain their medical record for safekeeping. Please feel free to contact me with any questions you might have. Thank you for your time and consideration.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069873  

 Lasik 2007. Severe dry eye since, burning, unremitting pain, 4 tear ducts plugged, blood serum drops, artificial tears, restasis, depression, post traumatic stress, on work disability since 2008. This experience has been beyond traumatic. They should ban this procedure if beforehand, there is no way to determine if you will get this. I had no previous history of dry eye or any underlying conditions.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1071085  

 I am reporting a problem with my lasik surgery. I was told by the doctor that lasik had a permanent effect. That was not true in my situation, i had monovision and had a dramatic decrease in the vision of both eyes 5 years after my surgery. The doctor still has info on his web site that the procedure is permanent. I ended up having the procedure done again at great expense. I would have thought twice in the beginning if i had known that there was a possibility of it not being permanent.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069890  

 I underwent lasik surgery to correct farsightedness. I was initially corrected with monovision. I was unable to see clearly from that day on. I was told that it would take time for my eyes to heal and make the adjustments for the monovision. So, i waited patiently but the vision did not improve, instead it only got worse. In 2007, i was given an enhancement to "delete" the monovision - that is what the practice called the procedure. I had explained on numerous occasions that i felt something had gone terribly wrong. I was given the same song and dance every time i called in. When the flap was being cut in my right eye they stopped mid procedure and started again without explanation. I was told that this is no cause for alarm, but i am hesitant now to trust anything they say or do. I am left with scar tissue on my right eye that extends from the mid iris area to the edge of the pupil and a little bit beyond. My distance vision in both eyes was excellent before the procedure. Now i am left with blurry vision in my left eye and my right eye is similar to looking through a kaleidoscope. It is always very dry and painful, even though i put drops in as directed. My night vision requires such a heavy prescription that it distorts everything around me, causing me to fear going out at night. My right eye no longer opens completely because of the sensitivity to light and dryness. The depression following this event has been the most devastating event in my life so far. I am not sure where to turn for help, and am unable to think clearly to even follow through and get some help. When i call around for a second opinion i am told that i need to keep seeing my original surgeon, and that makes no sense. I can tell that my eye is getting worse, and i am certain that one day soon i will be unable to see at all with my right eye.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1068318  

 Initial, bilateral, lasik surgery w/summit apex plus excimer laser for moderate myopia both eyes w/mild astigmatism right eye. Within 4 months, vision was 20/200 bilaterally and blurry vision, halos, starbursts and dry eyes experienced. In 2000, bilateral surgery performed utilizing ladarvision to correct residual myopia and astigmatism. At about 8 months later, surgery performed on right eye utilizing ladarvision to correct residual myopia and regression. In 2001, surgery performed on left eye utilizing ladarvision to correct residual myopia and astigmatism. The surgery(ies) resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts, loss of contrast and has made a negative impact physically, psychologically & financially. (see scanned pages).

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1067436  

 I had intralase, followed six months later by an "enhancement" with lasik. I had been told i was a good candidate and any risks were described as very minimal. Problems were evident immediately afterward and i was told repeatedly they would clear up. Several years later, while i have decent acuity, the quality of my vision is poor. I suffer from issues with glare, light scatter, see ghost images, halos and starbursts during the day. At night, i am almost blind. I lost much of my ability to function in the world and am also depressed and filled with remorse because i made the choice to have this surgery. Yet, i imagine, i am characterized as a success because i can read an eye chart from across the room. At my last appointment with the physician who did the surgery, he said, he remained terribly puzzled about my eyesight, acted almost as if he didn't believe me, and said, "well, there's a lot we don't know about eyesight. " if that were the case, i can't imagine why this surgery is marketed so heavily.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066827  

 A system operator reports a pt with overcorrections following bilateral refractive surgery. This report is for the left eye, the right eye is being reported under mfr report #3003288808-2008-00002. Pt records were received and reviewed on may 28th. The corneal flap was created by intralase and the pt received a conventional hyperopia with astigmatism treatment with a planned monovision outcome. At 1 month post-op, this pt was overcorrected by -. 75 diopter in the left eye. The left eye also exhibited a 2 line decrease in bcva. The surgeon was contacted on june 10th to obtain data on the pt's current status; however, the surgeon indicated, he was unwilling to provide additional info, stating there was no harm to this pt.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066036  

 Result of lasik procedure: left eye now has blurry vision, double vision, halos, starbursts, epithelial ingrowth, floaters, dry eye. Vision both near and far uncorrectable with glasses. Right eye: double vision, halos, starbursts, floaters, dry eye. Distance vision correctable with glasses.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064755  

 This letter addresses my concern about the safety of lasik surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on lasik, i decided not to do the surgery. I believe lasik surgery is not consistent with the ophthalmologist's hypocritic oath of "first do no harm. " statistics on complications could easily be manipulated by surgeons and i don't think their reporting of complications can be relied upon. I think a few points are more valid: it was reported in the last year in the literature that lasik surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the lasik flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When i have explained this fact to hundreds of patients who were considering lasik, everyone stated that it is enough reason not to do the surgery. I explained to them that it's as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won't do the surgery. When i have seen patients that have had lasik surgery with other doctors, none of them were aware of this fact. We are playing russian roulette with these patients, hoping statistically that they won't be hit in the eye. We are also playing this roulette game hoping beyond all hope that they don't get infection, but we all know infections happen. I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are lasik surgeons, why aren't we more concerned about the damaging effects of lasik which causes dry eye and damaged corneal nerves. They elected not to answer the question. I think we have a panel already in this country that is ideal to give you the answer to the problems with lasik. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don't do this surgery and ask them why they don't do it. I have seen other examples of where the fda allows higher risk manipulations of the eyes when it clearly is against the patients' interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence. The three examples cited in the letter, i. E. , lasik surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a "wow" factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over "first do not harm".

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064265  

 Received lasik surgery in 2007. Since surgery i have had much trouble adjusting to new vision including loss of near vision that was not a factor previously, even with glasses -pre-surgery- on for nearsightedness. This effect was not explained to me before surgery. I experience ghosting in both eyes, more severely in right eye. Both eyes experience starbursts, daybursts, halos, and glare. I experience double vision when i look to my extreme left that i did not have before surgery. I have had a noticeable increase in floaters in both eyes, but especially severe in the right eye. Both eyes are noticeably drier than before surgery. I never had any dry eye before lasik surgery, not even once. Distance vision is noticeably not as clear and sharp as before surgery with glasses. Overall vision is significantly reduced and less functional than before lasik surgery. Overall quality of life is significantly reduced as i have experienced and continue to experience digestive issues and psychological disturbances that directly coincided with lasik surgery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064245  

 I had lasik surgery and since then i have not been able to work for more than a half a day. I see double at times. My vision goes blurry and then i can't see up close or anything in the distance. I can no longer drive at night because of the halo effect. In low light areas, i strain my eyes so hard that i have pain. I had mono lasik and it has completely screwed my life up. My doctors office which is the lasik vision institute keeps telling me that i have extremely dry eyes and that it will clear up, but i have had no improvement and it seems to be getting worse. This could ruin my career and my life. When they tested my eyes before the surgery and found out how dry my eyes were, they should have turned me away, or at least informed me of the serious problems that were occurring because of dry eye syndrome. I am paying for surgery that has ruined my life. I don't know how the fda can continue to let these doctors perform this surgical procedure that ruins peoples lives. I am devastated over this and don't know what i am going to do.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134043  

 I had bilateral lasik eye procedure to correct distance vision. I awoke the next day to find that i had 20/20 distance vision, but i had lost my near vision. That was not the case prior to surgery and i do not remember being specifically warned of that possibility. I also developed dry eye, floaters, halo & glare that i was told would go away within a few months healing time. They did not. I also was not offered the option of only having one eye done at a time or was the option of monovision correction offered. I am an ultrasound technician by trade and i depend on being able to see near/computer and now i am burdened with having to wear glasses and having to pay off a huge amount of loan because i didn't want to wear glasses in the first place !! diagnosis or reason for use: improve distance vision.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134023  

 Severe dry eyes from lasik with wave technology. For therapy, currently using nocturnally heavy lubricant eye ointment of 41. 5% mineral oil, 56. 8% white petrolatum with eye mask to preserve humidity. Daytime use of lubricating eye drops.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1128165  

 Permanent visual problems resulting from lasik procedure. I was 20/20 with contacts prior to the procedure, and had no eye problems. I now suffer from higher order aberrations as well as dry eye. I have lost my best corrected vision and can no longer wear contact lenses, due to discomfort. This procedure has severely impacted my quality of life.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125904  

 In 2008, i was undergoing a lasik procedure. The doctor had just started the procedure on my right eye. The first part of the procedure required the use of a microtome cutter that cuts a flap in eye tissue to expose the cornea for the laser treatment. However, in the process of using the microtome, i experienced sharp very intense pain, the doctor made a comment like - "oops", or "oh know"- he explained that "i have to stop, i cannot do laser on you just now, we must do it later-, he then said that he needed to allow me to heal and that i had to come back the next day -friday- and saturday so he can see the healing. On friday, i was seen by another dr. He looked at my eye and i asked him what happened the day before, i also told him, that during and after the procedure, dr never told me what happened and since i was sedated during that procedure i was not thinking clearly. Friday, i asked this other dr what happened. This dr. Told me that dr. Had cut or nicked my cornea. I told him my eye hurt and i could not see out of it. Dr. Said that dr. Wanted to look at my eye on sunday. I am reporting this because i am a former bio medical engineer with experience investigating pt device failures. I will be seeking medical help from insurance co. Next week, however, medical literature shows that cornea cuts, and abrasions often leave permanent eye damage, i have been in much pain for two days, i am shocked and dismayed by the unprofessional behavior of my surgical doctor, i was injured because either the device malfunctioned or the doctor made mistake during the procedure. Thus, this is a reportable event.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125943  

 Lasik eye surgery resulting in partial blindness in right eye.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125983  

 In 2003, i had lasik surgery. Since that time, i have experienced extreme dry eyes and eye pain. On many days i cannot see much at all. I have had medical treatment for the dry eyes and pain with minimal success; the eyes will feel somewhat better for a short time only to become near debilitating again. Dates of use: #1. 2003, #2. 2004. Diagnosis or reason for use: #1. To improve vision. #2. I don't actually remember why they "enhanced" by eyes.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1120483  

 Prior to the lasik procedure, a treatment table from the wavescan 3. 9 software was generated that resulted in an induced astigmatism of 3. 2 diopter in the right eye and 1. 2 diopter in the left eye. In addition, the right eye received an over correction of 2 diopters. Pt's uncorrected visual acuity is 20/40 in the right eye and 20/30 in the left eye.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1111792  

 Received lasik laser surgery on my eye. Since that time, my eyesight has deteriorated terribly and i have permanent blurred and foggy vision. Diagnosis or reason for use: to improve eyesight.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1108803  

 I underwent custom vue lasik procedure in 2005. After the surgery, i have experienced the following problems in my left eye: approximately 1-2 months after the procedure, my tear ducts left eye completely closed and my left eye is constantly tearing. I have undergone surgery to try to open up the tear ducts, but the surgery was unsuccessful. Over the past 2 years, my vision left eye has been getting progressively worse and i have been diagnosed with ectasia -thinning/warping of the cornea-.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119026  

 A voluntary medwatch was received from the fda. Info indicates a pt experienced difficulties following bilateral lasik surgery. The report is for the left eye, the right eye is being submitted under mfr report # 1061857-2008-00169. This pt reports experiencing blurry vision, halos, starbursts and dry eyes 4 months following initial lasik surgery. The following year an enhancement was performed on the left eye to address residual myopia and regression. One year later, a second enhancement was performed on the left eye, this is to correct residual myopia and astigmatism. This pt stated these surgeries resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts and loss of contrast.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119083  

 A voluntary medwatch was received from the fda. Info indicates a pt experienced difficulties, following bilateral lasik surgery. This report is for the right eye, the left eye is being submitted under mfr report #1061857-2008-00170. This pt reports experiencing blurry vision, halos, starbursts and dry eyes 4 months following initial lasik surgery. The following year an enhancement was performed on the right eye to address residual myopia and regression. Eight months later, a second enhancement was performed on the right eye, this is to correct residual myopia and astigmatism. This pt stated these surgeries resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts and loss of contrast.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104239  

 An optometrist reports a hyperopic pt that is unhappy following bilateral lasik surgery. This report is for the left eye. The right eye is being reported under mfr report number 3003288808-2008-00008. The pt was a +5. 00 diopter pre-op and at 1 month post-op was +1. 75 diopter which regressed to +3. 00 diopter at the 7. 25 month post-op exam. Bcva remained the same as pre-op (20/20) and ucva improved from 20/200 to 20/100-. The pt reported difficulty driving at night due to glare and 'can't see as well as before the lasik'. This pt has a history of esotropia, and during the post-op period, the pt reported the left eye was 'turning in'. Additional info from the optometrist indicates this pt had strabismus and was likely an amblyope. The optometrist also stated the pt was becoming more presbyopic which was causing the pt additional frustration.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104240  

 An optometrist reports a hyperopic pt with a poor clinical outcome following bilateral lasik surgery on the right eye. This report is for the right eye, the left eye is being submitted under mfr's report number 3003288808-2008-00011. A 6 months post-op, this pt exhibited a 1 line decrease in the right eye and ucva went from 20/50 pre-op to 20/200 post-op. Additional info has been requested.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1103503  

 I had wavefront lasik surgery in 2004. I was severely overcorrected and had to have a second surgery 4 months later in early 2005. I have had severe dry eye ever since. I use drops almost every hour -systane nonpreservative vials- and get up at night 2 to 3 times to put drops in and still wake up with red, irritated eyes. My upper eyelids are always swollen and i get irritated eyes if i put makeup or moisturizer to close to my eyes. I have a lot of discomfort and get stabbing eye pain with headaches 2 to 3 times a month. It take two days of advil to stop the pain. I believe i am also uncorrectable. My optometrist hasn't specifically told me this but there is no change to my vision with different lens. I have to wear reading glasses to see within arms length now and didn't right before the surgery but needed to right after the surgery. I had to wear my husband's reading glasses to see at all until the next surgery. I was unable to read or write or drive a car for 4 mos.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1082580  

 A surgeon reports one pt with decreased bcva following lasik surgery. Follow-up with the surgeon indicates the patient's vision has returned to 20/20, the topographies look well centered, the epithelial irregularities have cleared with the use of dry eye medication and punctal plugs. The surgeon also stated the pt has not been harmed or injured. The surgeon did not provide any info regarding this patient's pre-op bcva measurement and has declined to provide any other info regarding this pt, and requested we not contact him any further regarding this matter.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1088924  

 Alcon received a voluntary medwatch from the fda. The pt reports following lasik surgery for severe hyperopia and astigmatism, she is experiencing a loss of best corrected visual acuity (she cannot achieve 20/20 in the right eye), halos, starbursts, dry eyes, ghosting and loss of contrast sensitivity. The pt also reports she no longer drives at night because the oncoming headlights obscure the road. In addition, the pt stated she had difficulty holding her eye still during the procedure,although the dr repeatedly instructed her to hold still. The surgery was 5 yrs ago, and the pt still has symptoms.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1089204  

 Alcon received a voluntary medwatch from the fda. A pt reports chronic problems and disability following lasik surgery. Pt records were received and reviewed. This pt was treated for a monovision outcome, the left eye being treated for distance vision, the right for near vision. During the post-op period, the pt experienced dry eye issues, trouble with depth perception in the left eye, difficulty reading newsprint, halos at night and blurry vision. The surgeon noted early dry macular degeneration approx 5 months post-op, blepharitis throughout the later post-operative period, and noted the blepharitis and dry eye issues were affecting the pt's vision. Following an enhancement on the right eye, the pt reported an improvement to the near vision, but the mid-range was not good. The pt continued to have near vision difficulties throughout the post-op period. At the last post-op exam provided, the pt experienced a decrease in bcva in the right eye from the initial pre-operative measurement.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1080832  

 Rptr reports that he had laser surgery in 2005 and now he has double and blurring vision and has to use many eyedrops. Reporter states that dr will not see him, or honor the warranty that he has. In oct 2006 rptr states that he had to have plugs inserted for dry eyes and saw a specialist and was told he had a refraction and his eye was the shape of a football. In 2008, pt had "lasik surgery touch up". Rptr states that he had 7 f/u visits and was told that he had scar tissue and an astigmatism and would have to wear an eye patch on his right eye. Pt states that he now has to have glasses to see after paying thousands of dollars for lasik surgery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081320  

 A surgeon originally reported a patient with topographically-observed "central islands" (corneal irregularities) following a custom myopia with astigmatism laser procedure. The patient's outcome following the initial procedure was reported under mfr report #1061857-2007-00332. An enhancement procedure was performed on a different laser platform from the initial procedure. This report is for the pt's outcome following that enhancement procedure. At approx 2 months post-enhancement, the pt's bcva is 20/80, a 4 line decrease from pre-enhancement and ucva is 20/400. Notes on the pt's records indicate, "right cornea has +1/2 reticular haze centrally with pericentral tough supero-temporally".

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081426  

 In the midst of my lasik surgery on my right/first eye. The dr announces that "we are dealing with a free cap". After he completes the surgery on the right eye that lasts almost half an hour, he tells me that "there must have been some mismeasurements". We can continue and run the risk of the same thing happening to the left eye or he can make some adjustments and hope we don't have to repeat free cap. At the time i was too traumatized to understand the full meaning of a free cap and knew i would never come back if i left at that moment. Fortunately, the left eye turned out fine. Unfortunately, there were not appropriate markings to replace my free cap in its correct position. During the next 12 months, i had 5 further surgeries to turn, stretch, stitch the free cap in its proper position. In the end, the amputated cap was removed. I now have to wear a hard contact to get any vision in that eye. It's very painful, irritating and stressful. The reason i originally had the procedure was to not wear soft contacts. I cannot get the hard contact out without a plunger and it is always painful.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081413  

 Lasik enhancement, 2 more subsequent enhancements, irregular astigmatism.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081298  

 Post operative data of a pt treated with the wavescan revealed an over correction of +2. 00 diopter in the right eye at one month following treatment. Pt's best corrected visual acuity is 20/25-2.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776  

 I had lasik surgery in 2001; a year later, my vision had worsened, so i had to have it again; to this date; i cannot see anything without rigid gas permeable contact lens that i can only wear for 8 hours a day; i'm literally blind without these glasses; i only wish i'd never gotten this surgery, because glasses don't even work. I'm really sad and depressed about this.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1174023  

 I had custom wavefront lasik surgery in late 2006. The treatment used an alcon ladar 6000 excimer laser system made by alcon refractive horizons. I had an adverse outcome, with under-correction and increased central curvature errors in both eyes. My doctor reported topographical irregularities to alcon, including a "significantly steeper central area". In addition to details of my specific case, the doctor also reported that the facility had experienced a substantial increase in the overall number of enhancement treatments required compared to their prior alcon ladar 4000 system. According to my doctor, alcon did not provide any info then and no further info was received from alcon until the ladar 6000 device safety alert was issued on february 21, 2007. I was given one additional enhancement treatment in the left eye in 2007 and two additional enhancement treatments in the right eye in 2007 and 2008. These procedures were successful in removing residual refractive errors but, since custom treatment was regarded as "off-label" for enhancement procedures, no attempt was made to resolve my high-order aberrations. I continued to complain of blurry vision, double images, glare and halos. More debilitating, though, were headaches i experienced in any vision-intensive activity, particularly with high detail and/or motion. Even routine activities like shopping became difficult. I continue to receive regular eval and monitoring from my doctor, but all treatment options through the local facility have been exhausted. I then decided to pursue other treatment options at other facilities, both regionally and nationally. I made numerous attempts to ask questions of alcon. Since alcon's device safety report mentioned topographically-observed central islands, but did not describe any of the island parameters, i asked alcon what range of topographic parameters they included in their use of the term "central islands". Since the device safety alert mentioned problems at other surgical centers, i asked for references to other doctors who might be doing follow-up eval and/or treatment of alcon ladar 6000 patients. Since alcon had collected considerable info from my personal medical records through contact directly with my doctor, i asked alcon to provide a summary report -without any patient's personally identifiable info-, including typical central island parameters, possible changes over time, and any additional treatments that had been tried at other facilities. The telephone number alcon had provided in the fda recall was not even the right department at alcon, so it took a number of days for alcon to decide who i should contact. Alcon's eventual response was not from any medically qualified staff person, but rather from their legal department, stating that they were unable to answer any of my questions. Alcon has also intervened and interfered with my attempt to enlist the services of another medical facility. Finally, when my doctor asked alcon many of the same questions, alcon also declined to respond to the doctor. As of 2008, alcon had not responded to even one of my questions or any of my doctor's questions. We know that alcon collected but, now that i need help from alcon to better understand the adverse impact of the ladar 6000 system, the info flow has stopped. Not only did alcon injure me through their ladar 6000 system, but now they are further adversely impacting me by continuing to withhold info that might facilitate my further treatment and recovery. Dates of use: 2006 - 2007. Diagnosis or reason for use: custom wavefront lasik.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1167205  

 Lasik: i first had lasik in 2000; had a second procedure that fall. Most recently had lasik in which the cornea was manual scraped because it was noted that i had map-dot-dystropy. These procedures have been done in an attempt to eliminate halos and starbursts, and increase vision acuity. As of this date, no improvement. I also have had dry eye since the original procedure. Tried drops and tear-duct plugs; neither worked. Both upper and lower ducts have been cauterized. Perhaps some improvement, but still very dry eyes.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1164204  

 Despite having good vision, i was induced to have lasik surgery to strengthen my distance vision for athletics - softball, golf, refereeing-. I was told i would have to wear "cheaters" to read. After the surgery my distance vision was improved, but it was difficult to read event with cheaters. After complaining i was told i was a good candidate for enhancement surgery-ck-. I was given contacts that they said would stimulate what vision would be like after enhancement. Both my distance and near vision were excellent with the contacts so i agreed to the enhancement. In the meantime, however, i had to have an aortic valve replacement. During this surgery, a clot went to my brain causing a stroke. I recovered from both the replacement and the stroke and was able to see except for peripheral vision to the left. I was given the ck enhancement with a resultant blurriness in both my distance and near vision. Now, a year after the enhancement and a huge expenditure and multiple pairs of glasses, i can only focus on images that are about 20 feet away. My life is ruined. I have always been very active physically but now can only shoot baskets in my driveway. I was a 3-handicapper in golf and can no longer break 100 and have to play with a spotter. I can only type and read with computer font magnification. It's like living behind a muddy windshield. Since i can see about 20 feet, the constant eye tests are a joke. In effect, i'm 20/20 blind. I need 20' golf tees, a step ladder and two caddies.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1158866  

 I had lasik eye surgery in 2001 with the eye surgeon's encouragement of how well i will see post-op. Well, the vision did improve greatly, but with a price to pay. I have suffered from severe dry eyes ever since the surgery. It's 7 years later and i am still suffering from the "uncomfortableness" of dry eyes. Now, though, i have to wear glasses again because my corneas are swollen to the point of causing blurred vision again. I just went back to my optometrist to get some new glasses and he said he had never seen a lasik pt's eyes vision drop this much in only 2 years from my last glasses change. Recently, my primary care doctor did an eye test on me with my glasses on and i failed that test. This is so scary. I am back to not being able to during the day, and even worse, is my night vision. I am scared to go out at night and drive, as all lights have a star effect. Very difficult to see. Two years ago i was started on restasis and had punctal plugs put in both eyes. The restasis did not help at all. The plugs in my eyes were also a disaster, as their tops poked and scraped into my eyes. My eyes were extremely red, painful, raw, and sore with those plugs in. One fell out about 3 months later. The other one just fell out about a month ago and i am so thankful to have it out of my eye. It was 2 years of pure hell having that thing scraping my eye. My current symptoms include: feeling like i have sand in my eyes, extremely dry eyes all the time, pain, progressive blurred vision. At night, during my restless sleeping, i wake up every hour or so with my eyes in pain and even more dry than during the day. I literally pour artificial tears into my eyes all night long. When i had this procedure done, i don't remember being told that this dry eye syndrome was a risk i was taking. I wish i had never had it done. And that says a lot from someone who wore glasses all her life and was so excited to think of having surgery to help me see better.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157865   

Image from lasik surgery, dr. The intralase flap cutter, and the alcon 6000 laser platform. When are you going to do something about lasik surgery? how many more people are going to be hurt?

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157867  

 Lasik surgery in 2008. Punctal plugs three months later. Dry eyes continue to date, cannot work a full 40 hour work week due to pain and discomfort. Difficulty seeing in low light conditions. Began taking anxiety and depression medicine about 4 days after surgery. Was hospitalized overnight for chest pains. Turned out that it was likely a side effect of the depression meds, but at the time i thought i was having a heart attack.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157868  

 I had lasik to correct my vision and now i have extremely dry eyes. I am using restasis - prescription, prophylactic antibiotics, artificial tears, genteal gel, muro 128 ointment. I do eyelid scrubs and eyelid warm compress twice per day. I have to wear goggles to ride my bike or do any outside activity. I can stand heating or air-conditioning if it's too near me. During my screening, i discussed the fact that my eyes were slightly dry. I asked if the dryness would increase after lasik. The doctor told me that they tested my tears and i wouldn't have any problem. The literature provided to me said that permanent dry eye was rare after lasik. I trusted my doctor and the literature provided. I am so miserable now. I have never achieved a point in 2 years where i felt that my eyes were stable and comfortable. I may have to undergo another surgery at some point to dry to correct erosions of my cornea. I have a condition known as abmd -anterior basement membrane dystrophy- which lasix center did not screen for. The dry eyes cause erosions and the abmd makes it very difficult for my eyes to heal. I feel that i wasn't given the correct info before making my decision to have lasik, and i will be paying for it for the rest of my life -monetarily and in the pain i constantly am suffering-. Lasik center definitely should be required to provide candidates with all of the risk factors prior to surgery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1153463  

 Eight yrs ago, i had lasik surgery on both of my eyes. Since then i have had blurred vision. Headaches, extremely impaired night vision and dizziness. The doctor who performed my surgery was let go which i later found out was due to his poor results. I was misinformed on many levels regarding the outcome and expectation of this procedure. I have since been back to that same practice where i have had 3 additional surgeries, and it has been highly suggested by this practice that i have a 4th. I have spent thousands of dollars on other physicians only to be told i am stuck like this. I am a mother of two small children and this is ruining my life! i was not a good candidate for this procedure as i have a large pupil size. I am angry, frustrated and helpless.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1151983  

 I had lasik surgery in 2007, monovision. My eyes felt wonderful but i did not adjust to the monovision. Six months later, on approx six months later, i had an enhancement on my left eye. A week or so later, everything went downhill. I had and still have severe dry eyes. It sometimes completely disables me. I have to keep my eyes shut and i cannot socialize, it shuts me down because of the extreme discomfort. It is now 2008, and it is still the same. I have started restasis and doing my 8th week. Praying that this will help me. I have figured out that the weather has something to do with it. The air quality. I just don't know what to do to take care of it before it affects me. I can sometimes go 3 weeks comfortably, but then it starts again and it is uncomfortable for quite a few days. I guess i really screwed up!.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1151948  

 Lasik -excimer laser- microkeratome created two short flaps. Doctor made two attempts in dominant eye. Lasik microkeratome cut two short flaps in dominant eye leaving two permanent scars causing streaks from every light source. Lasik procedure was aborted. Event in 1999. Reported here because saw an article about the web site, and so you can have better statistics.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1162023  

Rec'd a voluntary medwatch report from the fda. The rptr/pt indicated experiencing visual difficulties following bilateral custom refractive surgery for myopia. This report is for the right eye, the left eye is being reported under mfr report # 1061857-2008-00181. Following surgery, the pt reported large starbursting and halos under low light conditions; reduced low light contrast sensitivity; difficulty driving at night; corneal irregularities; central islands; high increase in floaters; and posterior vitreous detachment.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1135383  

 For the first 2 weeks after lasik, my eyes felt a little dry, but overall good. However, over the next few weeks, the dryness kept getting worse. By week 6, i had severe lasik induced nerve damage dry eyes. My eyes were bone dry and the pain was unbearable for the first 10 months post-lasik. I could feel the pain with every blink of every day. Even closing my eyes provided minimal relief. All the eye doctors could do was tell me to keep using artificial tears, put me on restasis, and put plugs in my puncta -the drains of the eye-. These things provided minimal relief. The pain was so intense with so little relief from existing therapies that i found myself researching suicide options on the internet. Prior to lasik, i was a happy family man with a good job. To think that i could find myself in this type of position because of lasik, an unnecessary fda approved procedure, was beyond belief. I am now over 2 years post-lasik and i suffer from senseless, permanent disabilities incurred from lasik. There are many things that i no longer can do such as being in a room with moving air from ceiling fans, heating vents, or air conditioning. I can only work limited hours due to the chronic post-lasik pain that i endure. I suffer from chronic eye pain that intensifies as the day goes on. I would write more but i don't think anyone in the fda who has any decision making authority reads these reports because if they did, i would expect that they would feel a shock to their conscience that the fda continues to allow people's eyes and lives to be ruined by lasik, a senseless, non-medically necessary procedure. I've heard lasik physicians compare lasik to other cosmetic procedures. That's absurd! if somebody has a poor outcome with breast augmentation, they can still go to work and/or drive at night. A person's eyes are their most vital sensory organ. If you damage a person's eyes, you damage that person in the most significant way. While it's too late for me and many others, it's not too late for future lasik pts. I request that the fda serve the public that you are entrusted to protect rather than serving the lasik industry.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134043  

 

I had bilateral lasik eye procedure to correct distance vision. I awoke the next day to find that i had 20/20 distance vision, but i had lost my near vision. That was not the case prior to surgery and i do not remember being specifically warned of that possibility. I also developed dry eye, floaters, halo & glare that i was told would go away within a few months healing time. They did not. I also was not offered the option of only having one eye done at a time or was the option of monovision correction offered. I am an ultrasound technician by trade and i depend on being able to see near/computer and now i am burdened with having to wear glasses and having to pay off a huge amount of loan because i didn't want to wear glasses in the first place !! diagnosis or reason for use: improve distance vision.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134023  

 

Severe dry eyes from lasik with wave technology. For therapy, currently using nocturnally heavy lubricant eye ointment of 41. 5% mineral oil, 56. 8% white petrolatum with eye mask to preserve humidity. Daytime use of lubricating eye drops.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1208863  

 

I had surgery in lasik center in 2008, i was farsightedness using 1. 50 glasses i went to have a consultation to see if i was a candidate for surgery, they said i was the perfect candidate and that it will be done in less than 10 minutes. The day of the surgery, a lady doctor who was going to perform the surgery told us that we may need reading glasses after the surgery, she never told us that i won't be able to see up to 8 feet or that i will have this problems that i am writing below. Discomfort of pain, blurry vision, dryness, glare, halos, starbursts around light, itching, scratchiness, light sensitivity, i can hardly see my face now, i cannot perform my job, i have been buying almost 30 pairs of glasses trying to fit one to my needs and my life, it is not the same any more. I am very depressed, grieving, desperate, they have ruined my eyes and my life, and the life of my family. Please help me. I don't know what to do now. I feel blind, i can do nothing.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1202339  

 

I received lasik on both eyes in 2006 at the laser eye center. Dr of the eye consultants performed the surgery. I experienced severe dryness after the surgery. I also experienced problem driving at night and watching tv. Some days were good and some were bad. When things started getting really bad, i went back to dr. After some tests, he concluded that my vision distortion is caused by a condition in the cornea, something he termed as 'keratoconus'. He also mentioned that my eyes could be susceptible to eventually suffer this condition, but most likely the progression got elevated by the lasik. He has signed me up to participate in a study called 'collagen cross-linking' of the cornea - at institute - where they use a combination of vitamin b2 and uv light to strengthen the corneal muscle. This study is my only hope. If this does not work out for me, then i would have to consider a corneal eye transplant according to dr. I seriously regret having done lasik. I am hoping that this complaint will help fda to help future potential lasik candidates to seriously consider all options before opting.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1196352  

 

A surgeon reports one pt with decreased bcva following bilateral prk surgery. Surgeon stated he is puzzled by this pt's outcome, all other results were 'wonderful'. This report is for the left eye, the right eye is being reported under mfr #3003288808-2008-000015. Pt records were rec'd and reviewed. Surgeon's preoperative notes indicated, "long term should be stable, 50/50 chance will need enhancement", which was discussed with the pt. The pt rec'd a prk procedure which is not an approved indication for this device and mitomycin was applied to the stroma directly following ablation, which is not an approved indication for this drug. Records indicate the pt noted seeing multiple images even with glasses prior to surgery, and at one month post-op the pt reported polyopia (multiple images), which continued throughout the postoperative period. Four diopters of exophoria at near were noted and the pt commented, "sharp pain on temporal side of the left eye while adducting". Pt comments included, "difficulty staying focused" and "shift in focus ability". During the postoperative period, the records indicate fluctuating refractions, discomfort, burning and foreign body sensation. At approx one month post-op, bilateral lower lid punctual plugs were placed to address dry eye symptoms. Add'l treatment for dry eye during the postoperative period included artificial tears and restasis. At 6 months post-op, the left eye experienced a 4 line decrease in bcva. Add'l info provided by the site indicates this pt rec'd an enhancement procedure approx 6. 5 months post-op. Add'l info ha been requested.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1193647  

 

In 1997, i had lasik surgery performed on both eyes. I had an enhancement in 2005, 1998 on my right eye. I now suffer from debilitating starbursts, halos, poor contrast and depth perception, and severely limited low light vision. Where i once was able to drive freely at night, i can no longer get around even on foot. Even in daylight i often mix up my own children with other people's children from distances as short as 6 feet away. I also suffer severe headaches from intense eye strain and the use of pilocarpine drops -. 5%-. Pre-existing conditions were: congenital nystagmus, myopia, astigmatism, night blindness - able to drive at night. My pre-operative readings were: measurement od os ou vcc 20/20020/40020/200 bscva 20/40 - 20/50, 20/10020/40 - 20/50. Refraction. -10. 00, -5. 75 x 010, 20/80, -10. 50, -6. 00 x 155. 20/200, 20/75. My current visual acuity is around 20/60 - 20/70 ou. Although i visited dr's office numerous times to seek help with the symptoms mentioned above, i was always told that everything was perfect and that these "side effects" were temporary and would go away, which they never did. In 2001, i finally gave up on dr and saw another lasik practitioner who informed me that i had decentered ablations, due to my nystagmus and that i was contraindicated for lasik at that time. I later learned that i also had significant higher order aberrations and was also contraindicated, due to the degree of my myopia and my pupil size.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1194159  

 

Cv treatment induced an unexpected +4 cylinder on a male pt.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1190204  

 

Ectasia in both eyes due to lasik surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1187773  

 

Ophthalmologist performed lasik surgery too soon after stopping wearing rgp contact lenses. He said my eyes were stable only 3 weeks after giving up these rgp lenses. They were not. As a result, my eyes continued to change drastically for several months after the procedure. I went from being myopic, about 8. 00 diopters to hyperopic. He also left me with very significant striae in my cornea, especially the left one. He tried to "iron out the wrinkle" the next morning. The visual lack of acuity continued for a long time and he would not tell me what was wrong with my vision. I finally was compelled to go to another ophthalmologist in the area, who said a special procedure had to be done immediately to try to get the striae out. I then had to go under this procedure which was not covered by insurance. This helped to a large extent. I could not, however, get a refraction for glasses or contacts for about 4 yrs that would correct my vision. I now have to wear rgp lenses once again. Eyeglasses cannot be prescribed as they will not work. Therefore, i can't correct my vision - for example when my eyes are inflamed or irritated- unless i'm wearing them.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1183965  

 

I had lasik surgery 4 yrs ago. I have been suffering from chronic dry eye since. When i first returned to the surgeon who performed the lasik surgery, he informed me that my surgical incision had healed beautifully, and that he did not have an answer as to the constant red eyes. After two yrs, and 200 bottles of visine later, i finally went to another dr who informed me that i had been suffering as a result of the lasik surgery. We gave our college aged son the lasik surgery as a birthday gift the same year!.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1177611  

 

Not sure of exact dates, but had lasik done about 18 months ago. I now have severe, irrepairable dry eye syndrome. The pain is debilitating, intense, and continual. I have been advised by dry eye specialists that the condition is permanent. How will i live when i get too old to apply the eye drops i have to use literally every 5 minutes? the worst is the massive and intentional lying regarding risks. The sales person told me that they had only ever had two individuals suffer significant issues post op. The surgeon himself misrepresented the risk. Dr. Himself told me verbally that the only instance of permanent injury was when a lady accidentally poked herself in the eye with a garden tool and peeled the flap back. He specifically told me the risks of severe side effects were ''very remote". I suppose dry eye syndrome is considered a "minor" complication. I should have noticed earlier that dr. Himself has yet to discard his spectacles. This quack of a money whoring surgeon should be censured at least, and preferably shot between the eyes for intentionally lying to me regarding the statistical risk profile of this procedure.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1232234  

 

There is epithelial ingrowth in both eyes and i can not see clearly near or distant both. Refraction test shows cylindrical, as well as spherical number in both eyes. All my jobs are suspended since the operation i. E. For the last 2 mos. Overall, the irregularities in the corneal surface is suspected to be responsible for all the existing problems.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1230095  

 

Approx 6 weeks after lasik surgery, i noticed that points of light at night are doubled -e. G. , instead of one red traffic light, i see two-. Surprisingly, i don't notice much of the haloing and starbursting that are usually described as lasik night vision problems. I have also noticed that i experience double vision in my right eye during the day time. This is most noticeable when trying to read a ruler or tape measure. All the graduation lines are doubled and i have to close my right eye to determine the correct measurement. I have also noticed a dramatic increase in the number and density of the vitreous opacitities -floaters- in my vision. This increase also occurred at approx 6 weeks post surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1226129  

 

VISX Laser: Severe contrast, low light issues from lasik.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1224224  

 

Lasik surgery- non wavefront- roanoke, va at eye care & surgery. Adverse event- g. A. S. H. - glare- arc of light- starbursts- halos- at nighttime & in low light settings.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1216517  

Dr. Performed my lasik in 2007. After the procedure, i developed chronic dry eye. I hadn't had this problem before the procedure and was not warned about it prior to the procedure. I went back to dr. Norden and he inserted plugs in my tear ducts and explained that women over 40 tend to have this problem. I would liked to have been warned beforehand so i could have made a more informed decision about this procedure. Now, over a year later, i still have plugs in my tear ducts and wake up in the middle of the night with difficulty opening my eyes and have to put drops in to be able to sleep. My eyes are sore, very dry, and puffy in the morning and i'm concerned about the long-term effects. I have been given a prescription for restasis but am afraid of forming a dependency. I thought that after all these years this procedure had been perfected and i knew all of it's shortcomings, and i'm very disappointed with the results. With all the problems, i would at least have hoped that i would have come out of it with perfect vision, but that was not the case. Dr. Offered to do the procedure again to fix my vision, but i'm afraid my eyes will just turn to dust if i take him up to it.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1215203  

 

I had lasik eye surgery from dr. In 2006. It was the biggest mistake of my life. Here is a list of my concerns: - my last checkup occurred last year, and i still remained at 20/15 on my right eye and 20/20 on my left eye. This is very misleading as things over 20 feet are blurry. They're especially blurry in medium to low lighting. I had no idea that my eyesight was definitely going to be worse afterwards. I thought since 20/20 was very likely, my vision could remain perfect at far from it. My vision also fluctuates depending on how much rest i get. I believe it's because the more i rested i am, the bigger my pupils are. Bigger pupils lead to seeing more through untreated parts. -they only treated my eyes partially and did not warn me of this. The treatment zone simply did not cover my entire eye. I have big pupils. The cut did not go outside of my pupils but within it. The outer area of my pupils remains untreated. I was not warned of this. I just cannot understand how they can get away with something like this as it has severely affected my vision for the worse. -i was not warned that i was going to get a permanent scar on my eyes. I believe it plays a big part of my blurred vision. -i was not warned that my night vision was definitelly going to get worse. I was very shocked the next day to see that my night vision definitely got worse. This should not be a surprise. I was simply warned about the possibility of getting starbursts and halos. I have a severe case of both. Based on the size of my pupils, they should have told me that the likelihood was high. -dry eyes are a constant problem for me. I've experienced loss of sleep and lack of sleep, due to extreme dryness that wakes me up or severe crust formations that did not exist before surgery. I was not aware that there are tests to determine how dry your eyes are. This should be a mandatory test. I have to put several eye drops a day- probably for the rest of my life. This is very costly, embarrassing, and bothersome. - i had red eye for about one month on my left eye. I had no idea that this could happen. It was very embarrassing to have it when i wanted to prove to co-workers and friends that lasik was safe and recommendable, but was i simply showing them proof that i made a mistake. The reputation of my judgement has probably been significantly damaged. -it takes a long time focusing on different distances. If i'm reading something and look up to something, it takes seconds to focus on it. This was always instant before. I was not warned of this. -the stats provided by the media and the ads are absurd. My surgeon asked me if i was glad to have done the surgery the day after. I said i was. He may have put that on record. No one's asked my how i'm doing now. Based on my own personal survey of people having done the surgery, most have regrets.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1213589  

 

I had lasik in both eyes in 2008. I had high prescription of contacts at a -8. 50 in left eye and -9. 50 in right eye. Very high prescrip. My surgeon, dr diagnosed me with dry eye before i had surgery when he was doing some tests. I shouldn't have had this surgery. After surgery, i saw like a freak immediately, though mostly clear, my world has turned upside down. My floor is crooked, my walls are stretched, circles aren't round anymore, my eyes were changing constantly being even one whole diopter different, i was overcorrected, and eventually when i got stern enough, he finally told me i had both decentered eyes. A nightmare i still live with everyday. What was not told to me until i gathered enough information from 15 docs or so, -most of whom would not tell me, only found out because i insisted on my records, that is, if they chose to put what it really was, i found some do not even write what they should on the charts- i found out i had epithelial ingrowth, blepharitis, corneal haze, corneal swelling, post-op astigmatism that the laser gave me!, irregular flaps, and some more i probably don't remember right now. One month after surgery, after my lying doc said all i had was overcorrection, -i knew he had to be lying- i went for a second opinion at laser center and saw another dr od, who worked for dr(third)- he told me i was fine, i just saw freaky because i had such a high prescription and it would take a long time to heal -more lies- then said i too had corneal swelling- of which at that time i didn't know you have to treat with steroids. He did not treat me, told me to see my surgeon in the next week and sent me on my way. Well, because he didn't treat me, and i got to my surgeon too late, i now live with unbearable permanent damage from the corneal swelling seeing a ghosty line around everyone and everything and have no 3dimensional vision all due to him not treating me- i had an episode on the following month, where everything i saw had changed. Mind you, on top of the freak world i "already" lived in with moving, crooked walls, distortion, crooked floor, etc. -and you know what dr(second) saw in my charts that i had dlk-therefore i even had pred forte on my counter and could have taken it till i got to my surgeon if "he" didn't "want" to treat me, and i wouldn't be living like this, had he told me what was going on and how i could fix it or event that i should see my surgeon asap today!, if he wasn't going to help! good thing i have one honest doctor i can now turn to. But the damage is done and not repairable, and believe me if you had to live like this, you wouldn't want to. It's god awful existing this way and being "forced" to see things so wrong. After thousands of dollars spent, i have contacts that help some, but guess what i will never see normal again. Well, i guess i must add, that i do have severe dry eye, of course halos and starbursts, and of course, loss of contrast in a big way. I also have corneal thinning, because i also have only 219 microns left in my left eye and not much more in my right. I fear ectasia, cataracts, corneal transplants if corneal swelling continues, which i've already had again this year! lucky i know now, to go in right away and my new doc "does" treat me. I miss my beautiful world. Can't seven see my own face straight; even with contacts. My nose moves because it is a different shape in one eye than the other, as well as all things being different shape, too. I went in thinking i'd have a miracle, and ended up hating life, trusting none, but one doctor, and having my life turned upside down and never being able to get past it, because it's always "in front of me"! imagine! could you endure? going through a day in life, is no fun and very scare, every day! you know what, even the words on this screen typing to you, do not go straight across, dipped in the middle, up on one end, down on the other and swerved. Can you even fathom living like this? the machine used on me, was an alcon ladarvision 4000, and if i went to a second opinion doc, and i wouldn't let them known who my surgeon was, they'd just ask what was the machine used. I bet it's a faulty machine on top of finding out the doctor has a bad reputation. I've also learned of people who went to well world renowned docs and still had irreversible damage. I just don't think lasik should be done, period! i was responsible for deciding on this surgery, but the truth is, i trusted the doctors know what they are doing and would never do a surgery that would harm, if they knew it did, and i found out the worse, which is they do know it harms! included with that is all the hype that's it's virtually a piece of cake, and foolproof, to find out later the ruth is so many are harmed, -i've met those with transplants, now and who are blinded- and none of us should have to live like this. I had a great future ahead. Had, is how i feel. L:ife will never be the same! thanks for listening.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1212026  

 

Complaint description: my optometrist of 20 years, dr at vision center recommended another dr to do my lasik surgery on my eyes. When i asked which office he was at, dr(first) told me that he was out of the office. I had eye surgery in 2008 at the office with dr(second). Immediately that night, i experienced problems. When i tried to call vision center, we only got a recording. There was no emergency number listed on the space for phone numbers on the papers that they sent home. When i paged dr(first) there was no response. At 1am on the next day, a friend drove me to the er. They too tried to page dr(first) and tried to call dr(second) and vision one. All the doctors could do for me at the er was to prescribe a pain pill and sedative, -which should have been prescribed by second dr to begin with-. The er visit cost almost $500. I continued to have problems and went to see dr(first) my optometrist. He really didn't know what to do because he is not a surgeon. He said i should just keep putting drops in my eyes and it would get better. When dr(first) took the contact bandages off, my right eye got worse immediately. I called up dr(first) and he said that i needed to give it time and it would get better. My eye was too painful to be able to see and i was not able to work. After a week and a half i returned to dr(first) and by that time i had serious issues with my right eye. After talking to second dr by phone, i was referred to an eye surgeon, another dr. I went to dr(third) and he had to perform surgery to lift the flap on my right eye and clean underneath it due to growths around and under the flap. My eye was very painful all over again, and i was not able to see clearly or work. I continued to see him a few times a week for several weeks. It was at that time i learned dr(second) does not live in town. He lives in another state. That is the reason why he could not see my when i developed problems. If i had known that he does not live here, i never would have used him as my lasik surgeon. Now after several mos of going out for appointments with third dr, i still can not see out of my right eye. It is like looking out of a blurry dirty film. It can not be corrected with lenses or glasses. I have to have another surgery on nov. 6 and dr(third) says i will need another in 4-6 mos. So far i have been billed for thousands of dollars and that does not include prescriptions or patches that i had to buy. That does not include the surgery on approx five months later, or any future visits to dr. Foulkes. I have had to miss weeks of work due to pain and loss of vision. I have had to take off work to drive out to hinsdale to see dr(third) many times. Lasik surgery performed by second dr on original date. Follow up care by dr(third) to try to correct problems. On ten days later, corrective procedure performed by dr(third) to lift flap of right eye to clean underneath. On the next day, follow up care dr(third), two days later follow up care dr(third), three days later follow up care dr(third), the following month(two days later) follow up care same dr, five days later follow up care same dr, three days later follow up care same dr, a week later follow up care same dr, the following month follow up care dr, eighteen days later follow up eye surgery to clean under flap in right eye by dr, three days later follow up care same dr.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039137  

 

I had lasik surgery to correct my vision. I now suffer from extreme severe dry eyes. I use drops every 1-4 minutes in each eye. The surgeon still has me using the sterile drops and has me taking various supplements. He has also permanently plugged my tear ducts. Our monthly bills for drops and supplements! i am also in constant pain. I cannot drive at night or see well at dark. My day activities have been altered drastically. I cannot do so many activities due to eye pain, and needing to stop and use drops every 1-4 minutes. My vision is fuzzy at all times, except for about 5 seconds after administering the drops. I cannot read road signs or see faces. Of course i fear the worst, which is blindness. Because of pain and extreme light sensitivity i have to always wear dark glasses. As far as i can tell from my records, i was never asked or tested for dry eyes prior to the surgery. I thought i was suffering alone until the recent reports have been highlighted. My husband, parents, and relatives are chiropractors. They have me on the best supplements for dry eye, but nothing has helped much. If you know of anything else out there, i would be most thankful for your advice. Respectfully. I don't know the name of the machine used, but the date was 2007.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039138  

 

I flew to have perform lasik on both eyes. Since, today's date is 2008 and going on 9 years, my vision has been distorted, i have dry eye syndrome, decentered flaps cut from the microkeratome blade, and an uneven laser reshapement, permanently thinning out my only corneas further ruining my vision for life. I have spent, trying to return my vision to normal with no luck. I have traveled around the world and have seen the best doctors, all with no fix in line. My own dr, has lawsuits and has continued to lie to myself and my family about the lasik procedure going wrong, very wrong, horrifically wrong. I want a complete investigation of my dr's lawsuits, his lies, and his unprofessional ways. He has harassed my family, attempted to sue us to the tune -he failed- because of my website that warns the masses about lasik and lasik doctors like him. I want justice. Lasik will never be safe because it is still unpredictable surgery. One person it works for, and the next go blind or have complications beyond control to deal with. At least with contacts or glasses, you can get by with sane vision. The consent form is a joke at best. It does not give the consumer all of the known and unk symptoms, side effects, and long -term problems that it should be giving them. It protects doctor while injuring the pt. Complaint and investigation on: the vision center.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039140  

 

In 1992, i lost my vision after refractive surgery - rk. In early october i had gone to a "free" seminar to gather info before i saw a dr. I had pre-existing scar tissue on my left eye but dr said "no problem", and we proceeded with bilateral refractive surgery. I did not have good vision from the start. I was told that "things have not settled down yet. We can always perform an enhancement. " i struggled with my duties at home and work. In 1993, i went to another city to see another dr -a referral from dr(first)-. He performed a prk on my left eye with later plans to surgically improve the right eye. At that time second dr told me that dr(first) made the cuts in my eyes too deep and too long. My left eye now had vision worse than pre-prk and was covered with scar tissue from the laser. In 1995, i went on medical leave from my surgical nursing position and had a corneal transplant. During that year, i filed for disability retirement. In 1996, i went to jury trial -case, medical malpractice. I was the victim made to look like a perpetrator. We lost the case and threw ourselves into debt. Dr(first) told me i was a good candidate for refractive surgery, that i would have good results and could throw away my glasses. He never told me there was no turning back from this surgery. He never mentioned the star burst, night blindness, double vision or painful dry eye. He never mentioned that i would not be able to care for my three children. I live the nightmare every day and cringe when i see the same advertising today as when i had my disastrous eye surgery. Dates of use: 1992 - 1993. Diagnosis or reason for use: rk cutting device and laser for prk procedure.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039141  

 

Event: bilateral lasik refractive surgery to correct nearsightedness. Outcome: initially corrected to 20/25; about 3 months after surgery, regression began, causing nearsightedness to return and requiring use of expensive custom contact lenses to achieve 20/20 vision. Night vision severly damaged: corneal surfaces healed with a non-smooth surface, causing severe higher order aberrations -hoas-, which cause visual disturbances, including: large starbursts when looking toward any light source, such as car headlights. Multiple -more than 20- images of bright objects. Much poorer ability to discriminate objects in dark or dim rooms. Night vision disturbances and hoas cannot be corrected with glasses, or with most types of contact lenses. Require expensive custom-made large diameter rigid gas permeable -rgp- contact lenses. Annual expense for rgp lenses and special cleaning solutions: for first pair of lenses -including professional fees- with duplicate lenses for each lens. Annual cost of cleaning solutions and devices; dry eye caused by lasik causes discomfort when using corrective contact lenses.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047150  

 

My lasik experience: after initial surgery in 1998, then enhancement in 1999, my vision in both eyes, uncorrected was 20/20. This was truly a miracle for those of us so dependent upon contacts and glasses. I remember disposing of all my old contact lenses and extra cases. No more lens cleaning, scrambling for glasses at night, occasional discomfort etc. This visual quality of life lasted 9 months. Then, gradually the sight in my right eye deteriorated to 20/100 by late 1999. I also noticed declining vision in my left eye, just to a lesser degree. My lasik process from the outset was being handled by both my local od and surgeons from the nearby medical school clinic. Neither could understand this change but both concluded that in early 2000, i should undergo a 2nd enhancement on both eyes. The outcome of this 2nd enhancement made no improvement and further thinned my cornea to less than 250m r and 275m l. Eventually, ectasia or keratectasia became the diagnosis and rgp lenses were prescribed. My average best corrected post lasik vision with a rose k rgp in the left eye is 20/25 and a boston scleral lens in the r is 20/40. Typically, i am able to wear my lenses with reasonable comfort up to 15 hours daily. Unsuccessful results: unsuccessful results as in my situation, tend to lead to various complications such as ectasia or keratectasia, dry eye problems, depth perception difficulties, and in general, intense disappointment. Most likely, the real reason for unsuccessful outcomes in the pre lasik screening and preparation process was not adequate and the surgeon was too aggressive in the degree of correction. Also, as is the case in all vocations, there are some physicians who are simply not qualified. Another contributing factor to complications after lasik surgery can occasionally be the result of obsolete or faulty calibrated equipment. Lastly, is the fact that fundamental mistakes are made even by the most qualified doctors. I believe and again emphasize that if attentive pre lasik screening is adhered to, reasonable margins for error are considered, and detailed checks and balances are built into the lasik process from beginning to end, complications as a result of lasik surgery can be significantly mitigated. When you get to the stage many of us are in, anger, frustration, and major disappointment is natural. We ask; why did this happen? what should i do? what will be the final result, i. E. Will i end up blind? although still very difficult, i try to objectively negate or offset many of these disappointments and concerns by concentrating first by simply coping but secondly and most importantly, focusing on the prospects that better treatments for ectasia, kerataectasis, and keratoconus are being constantly developed and in the not too distant future, a long-term viable solution will emerge. Detailed history: 1998: preop exam, manifest r -7. 00-1. 75x030 20/20. L -6. 75-2. 25x162 20/20. On the following month: two week status post lasik. Visual acuity without correction 20/25 r and l. Manifest r -0. 50 sphere 20/20. L -0. 75 sphere 20/20. In 1999: three months status post lasik. Visual acuity with out correction 20/20 in the right eye, 20/25 on the left eye. Manifest r -1. 00 sphere 20/20. L -0. 25-0. 75x130 20/20. On approx three months later: six months post lasik. Visual acuity with out correction 20/50 in the right eye, 20/25 on the left. Manifest r -1. 00-0. 25x010, l -0. 25-0. 75x140; 20/20 vision in both eyes. On approx six months later: visual acuity with out correction r 20/60, l 20/40. Manifest r -1. 00 sphere. L -0. 75-1. 00x145, 20/20 acuity in each eye. In 2000: 24 hr post lasik enhancement. Visual acuity with out correction 20/20 in the right eye, 20/20-1 in the left eye. Manifest r plano-0. 50x050 and 20/20 vision l -0. 25 sphere 20/20. Two wks post lasik enhancement. Visual acuity 20/20- right and left eye. Manifest r plano-0. 50x055, l-0. 50 sphere 20/20 vision in both eyes. In 2000: three months post lasik enhancement. Visual acuity without correction 20/25 in the right eye, 20/20 in the left eye. Manifest r plano-0. 75x055 20/20 vision and l plano-0. 50x140 20/20 vision. On approx three months later: six months post lasik enhancement. Visual acuity without correction 20/30 in the right eye and 20/25 in the left eye. Manifest r -0. 25-1. 00x065 and l -0. 25-0. 50x130 20/20 vision in both eyes. In 2001: one yr post lasik enhancement. Visual acuity without correction 20/100 in the right eye and 20/50 in the left. Manifest r plano-3. 50x086 and l-0. 25-0. 50x130 with 20/20 vision in both eyes. On the following month: preop for lasik enhancement #2. Visual acuity without correction 20/100 in the right eye and 20/32 in the left. Manifest r was -0. 50-3. 25x081 and l -0. 25-0. 50x 130 for 20/20-3 in the right eye and 20/20 in the left. On approx seven months later: visual acuity without correction was 20/100 in the right eye and 20/32 in the left. Manifest r -0. 25-4. 25x094 for 20/25 acuity and l -0. 50-0. 75x115 for 20/20. On sixteen days later: lasik enhancement #2. On the following month: two weeks post lasik enhancement #2. Visual acuity without correction. Was 20/50 in the right eye and 20/25 in the left. Manifest r plano -0. 75 x 040 with a variable response for best corrected visual acuity of 20/50 and l plano -0. 75x135 for 20/20. On approx three months later: three months post lasik enhancement #2. Visual acuity without correction was 20/50 in the right eye and 20/25 in the left. Manifest r -0. 50x1. 00x060 for 20/40 acuity and l pano-0. 75x 135 for 20/25 visual acuity. Since the enhancement #2, continuous central pek worse in the right eye than the left. In 2002: five months post lasik enhancement #2. Visual acuity without correction was 20/100 in the right eye and 20/30 in the left. Manifest r -0. 75- 2. 75x35 for 20/20 visual acuity. Irregular steepening in the central cornea, mild pek, confirmed central comea ectasia. On the following month: contact lens fit od that achieved 20/25 vision. One and a half months later: change in visual acuity in the left eye. Manifest refraction l plano 1. 75x 50. On four weeks later: initiated rgp fitting of the left eye with visual acuity of 20/20.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039109  

 

I had lasik surgery performed in 2005. A year's long problem with dry eye syndrome, itching of the eyes, there were days i came home from work and wanted to rip my eyes out, they itched so bad. Had lots of blurred vision, was put on restatsis for 6-9 months. The hospital where i work -i'm a veteran- put permanent plugs in both bottom tear ducts to help with dry eyes, but this created a lot of fluid build-up at night to where my vision was even blurrier. My provider who performed the surgery eventually told me to blow dry my eyes every morning. What a joke, i paid him 4,000. 00 to have all these problems. If i had this to do over again, i would never have had this procedure performed.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039110  

 

Lasik surgery that has resulted in ghosted vision, reduced night vision, halos, reduced vision in dim light, and loss of contrast in dim light. Diagnosis or reason for use: nearsighted -4. 25, no longer able to tolerate contacts, glasses cause.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039111  

 

Had a lasik procedure completed that resulted in reduced vision in my left eye and improved vision in my right eye. In the process of creating the corneal flap, the entire cornea came loose and had to be stabilized with a contact after the procedure. The complication was labeled normal, and my claims of blurred vision and poor outcome were not taken seriously by the facility that completed the procedure. However, i am a nurse and had a chance to speak with an ophthalmologist regarding the procedure. The ophthalmologist attributed the poor outcome entirely to the error of the unsuccessful flap creation in the left eye for the laser. Lasik surgery in 2007 laser.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039112  

 

I had lasik surgery in 2006, and have suffered significant eye health issues ever since. While my eyesight is good, i developed superior limbic keratoconjunctivitis -slk- and severe dry eye syndrome. According to webmd, "it is believed that slk is present secondary to superior bulbar conjunctiva laxity, which induces inflammatory changes from mechanical soft tissue microtrauma. " ophthalmologists treated the slk with drops and environmental modifications for a full year with no success. I have since reluctantly had additional surgery - conjunctiva resection on both eyes, but am still experiencing problems. My ophthalmologists say they cannot begin to treat the dry eye syndrome until the slk is brought under control. Unfortunately, the lack of an adequate tear film aggravates the slk. I believe this vicious circle was directly caused by lasik surgery. Neither the surgeon nor the surgical center where i rec'd the lasik adequately warned me of the dangers. Although it was not bothering me at the time, they measured my tear production, determined i had dry eyes prior to surgery and started a course of restasis. Knowing what i do now, that alone should have disqualified me from the procedure. I urge the fda to mandate stronger criteria to disqualify people for this procedure and to promote additional pt education prior to surgery. Dose or amount: bilateral surgery, frequency: once.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039113  

 

I received lasik eye surgery two years ago. Since that time, i have had three "touch-ups" due to poor results. These poor results include: - blurred vision - dry, itchy eyes - a feeling that something is "in there" - extreme sensitivity to light - fear of night driving.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039114  

 

After effect: night halos, especially while driving; dry eye; noticeable weakening of correction within 18 months of procedure. Glasses required for night driving. Pre-procedure: despite requests, i was never able to speak directly with the operative surgeon until moments before the procedure and then, only just briefly. There was no substantive contact with the surgeon, ever, even post surgery. Also, pre-procedure, i was shuffled between two optometrists in the office and had trouble getting consistent info about the details of my correction. It felt like a mill; i was just one of the masses. P. S. Despite the problems, i feel that lasik requires a risk-benefit assessment for each pt. I suffer these after effects, but if i had the option to choose the procedure again, i would probably do it. The benefits outweigh the after effects. For others this may not be true. It is an assessment that each individual must make. If i could do anything differently, it would be to interview more facilities/physicians, instead of just going with the one who i thought had the best record. I should say, also, that i chose mono-vision so that one eye sees far away and the other sees close. I do not need glasses for reading or distance, only for driving at night due to halos. I do have some trouble with intermediate distances, say three to four feet.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039121  

 

Lasik surgery flap not sufficient to proceed in left eye, device did not fit eyelid. Redid surgery in several months, 2006, using another technique. Painful dry eye resulted immediately in both eyes from original lasik surgery and has not remitted fully, although, improved with daily use of expensive eye drops - cyclosporin.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039122  

 

I was overcorrected in my left eye as a result of wavefront prk with the visx excimer laser. Not only that i have, terrible side effects in both eyes -gash- which greatly affect my night vision and vision in low light situations. Mild dry eye is also problematic. For a procedure that was supposed to make my life easier, it has made it much more difficult and complex on a daily basis. I so very wish that i could go back to my vision with glasses. Not a day goes by that i am not reminded of the adverse events following my prk. Date of use: 2006.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038013   

 

Laser vision correction surgery. An inexperienced surgeon or defective machine cut flap too deep leaving a bulge on my eye. Second surgery in 2005 -by the same surgeon- to remove bulge, damages the cornea and leaves me with the uncurable eye disease pinguecula. The surgeon contends i have dry eye.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038108  

 

Dear sir/madam: please be informed that i had a lasik surgery in late 1996 at the hospital by a dr. I have written you a certified letter on 04/28/2008 in reference to the problem, and i have also written certified letters through the years to medical entities, and political officers. Dr did a malicious act by masking half of my cornea and created fluids under the cornea flap to conceal the immediate results. I have been all over the world to see if something can be done to correct my cornea, but nothing can be done. In my letter to you, i have enclosed tomographies, so you can see that only a human hand could have covered half of the cornea and create fluids under the flap. Currently, my cornea is irritated, i can't wear contact lenses, and i can see triple images. I hope your agency shall investigate this matter and bring dr. Mcdonald and other doctors like her to justice. If doctors like dr are left unchecked, the problems doctors injuring patients will not go away, and we will have an injured handicapped and unhealthy society. Sincerely.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038117  

 

Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference from l to r eye. Left eye also still has bad astigmatism, had to get prescription reading glasses for one eye to slow down headaches. I paid the extra per eye, for lifetime touch up. After waiting 1 yr, i went back to see if they could balance out the eye better and was told no. Unless they get worse than 20/40 they would not do it. That was not told to me at the time of surgery. Why pay the extra money then? i am now very light sensitive. As my md told me, photo-phobic. The need for sunglasses is all the time and i have even had a few episodes that were so severe that i had to pull over when driving. It is interfering with my work. Floaters or what i would term as dirt floating around in the eyes, which is really loose blood vessels. I was told that these would go away after a few weeks as they started shortly after the surgery. It's been a year and a half and there's still a lot of them.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038120  

 

After lasix surg: i had preexisting ectasia which went undiagnosed by the dr. He took 2 thermal photos on two separate appointments that now we know clearly show red, thin areas of the cornea. After the first surgery, i could not see as well as before surgery and dr kept saying it will get better. Never did. He did what he called "an enhancement" which he said would re-center my vision, removing even more tissue. He was going to do a third procedure "enhancement" and was stopped by the head of the eye dept at the out of town hosp where the surgery was done. I see halos, star bursts and now have to wear contacts to hold the cornea down. Dry eyes is a huge problem. Night driving is pretty much not possible except in emergency. Long drives to parents and friends is not something i can do anymore. Lost 30 peripheral vision as well. Just about ruined my life and dr never said, i'm sorry. No help at all.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038128  

 

I had lasik surgery two years ago. Mostly it has been perfect, but my night vision is awful now. It used to be very good. It's almost scary to drive at night. Especially when it's raining. I never had that problem before. It's like when the sun shines just right into a camera and the light spreads and blocks stuff out. Also i see the halos around duller lights. My vision during the day is fantastic.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038131  

 

Lasik surgery. I was not a good candidate having a size 7 pupil and -10 1/2 refraction with astigmatism. My night vision is impaired and have to stop driving at night. Have starbursts and very dry eyes which affects vision. Had extreme pain after surgery and 4 months of very little vision. Ten years later i have macular degeneration in one eye which has further debilitated my sight. The surgeon said i was an excellent candidate which was clearly not the case.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038099  

 

Following lasik surgery, i have had problems with serious dry eyes. Every morning i must use eye drops and most nights as well. In addition, in the dark light objects have sunbursts.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038103  

 

I was talked into having rk-radial keratotomy- on my eyes by dr. He said, he never had a problem with any of his surgeries and guaranteed me a successful outcome. After the surgery, however, my eyes became very fatigued and sore. He said that i was reading from the twenty-twenty line on the eye chart and that this problem is in my head. He offered no support or guidance in this matter whatsoever, and practically dismissed me. I was shocked. Now i was left with sore, tired, fatigued eyes and no answers, since this was a new procedure in our area. So i began a journey to try and find a solution. This journey has taken me to numerous prominent eye surgeons. The have prescribed soft and hard contact lenses, glasses, performed ck-conductive keratoplasty-, lasik twice, and nothing has really corrected the problem. The pitfalls of corrective eye surgery need to be honestly discussed by these eye doctors, not covered up by misleading advertising and hype. Thank you for your time and concern in this matter.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038104  

 

Lasik surgery. Extreme pain in eyes lasting 2 weeks. Had to stay in darkened room for a month. Since operation every thing is dim. Very difficult to drive at night, halo and sparkler effect from lights, extreme dry eyes.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038106  

 

Lasik surgery was performed with less than desired results. The patient requested clear distance vision and the results were clear close-up vision with maintained distance vision requiring corrective lenses. Lasik was performed again on the left eye with better results, but still less than desired. In 2007, cataract surgery was performed on both eyes to obtain desired results.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036129  

 

Was supposed to have lasik surgery, but had prk because the md said i did not have enough cornea. Prk in early 2008. That night the bandaid lens fell out of my left eye and formed a corneal abrasion. After many visits back to the md, and he stating everything looked good for about a month. I visited another md because my eye looked like it was going to fall out of the socket. The 2nd md stated i had a terrible infection behind the cornea. He treated me aggressively for about 2 weeks. No improvement with many eye drops and daily visits to the md. The md stated that he had to do an emergency corneal transplant or i might loose my eye. I have a permanent disability 20/70 in my left eye. I continue to have discomfort and i am recovering from shingles of the eye. My outcome for vision is not good. I had 2 other md visits and they both agreed regular lasik surgery was much better, and i had enough cornea flap. I feel that the first md from lasik plus in tampa fl neglected my care and eye. He never addressed an infection. I was put on large dosages of pain killers and tranquilizers and sleeping pills for the pain. Each time i would visit the md, he would say 2 more weeks and you will be healed. If i would have not gone to another md, i would have lost my eye.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037947  

 

Laser: VISX S4

In 2007, i underwent lasik vision correction surgery. I was screened and declared a perfect candidate for the surgery. The surgery itself went exactly as planned with no "surgical" complications. According to the dr, the healing process also went normal and i was declared to have an excellent outcome due to my low refractive error. However, in spite of this, the results of this surgery were actually disastrous. Although my post-surgical refractive error is quite low, the surgery induced a significant level of higher order aberrations, including a highly abnormal level of spherical aberration and coma due to a correction zone that is much smaller than my scotopic pupil size. I see fine in direct sunlight and natural lighting, but have difficulty seeing clearly under normal levels of indoor or artificial lighting. I can not see clearly in many indoor environments during the day, particularly on overcast days, and i have consistently poor quality of vision indoors in the evenings due to significant loss of contrast sensitivity. I frequently experience halos around indoor lighting. It is also very difficult to drive at night due to significant starbursting on all light sources, which results in a significant loss of depth perception. I can not enjoy many leisure activities such as watching movies. Watching television with lights on can be quite challenging due to poor quality of the image i see, and going out at night is difficult. None of these vision quality issues can be reliably corrected with glasses or contact lenses, and when dealing with eye drs, i find that my pupils are now considered to be abnormal and i'm lumped in with individuals who have diseased corneas. Although i did sign an informed consent form, this form was treated as a formality and it was represented to me that with the latest wavefront technology, the types of complications detailed in that consent form were mostly a thing of the past. I also expected to be notified if i was at a higher risk for any of those complications -i. E. Due to my larger than average pupils, etc. , but was not adequately notified of my higher than average risk factors. I have spent a significant part of the last year trying to cope with the emotional turmoil and anxiety that have resulted from the loss of visual quality from an elective surgery that was supposed to improve my quality of life. I did not need this surgery, and based on my results, it clearly is not as safe and reliable as it was represented to be.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038014  

 

Lasik laser eye surgery - sight is good, but dryness now coming on two years has not improved.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038017  

 

I had lasik eye surgery approximately 5 years ago. I did not receive 20/20 results, but did experience exceptional clarity after having very poor vision for some time. In the last 6 months, i noticed that my vision seemed to worsen. It was not as clear as it used to be. I could not read as far away as i used to. I am aware that the natural deterioration still occurs due to aging of the eye, but did not expect to experience this at a young age. I have trouble driving at night. My eyes are exceptionally sensitive to light -specifically during nighttime- and i find it hard to focus. Lasik summer - 2003.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038018  

 

Had lasik surgery. Results, eyes tire easily, difficulty focusing, blurred vision, blinking, difficulty reading, avoid evening driving.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038021  

 

Lasik: developed fungal infection under corneal flap os during one of multiple relifting and smoothing procedures as follow-up to surgery -to remove corneal wrinkles. Referred to ophtho dept; many photographs taken. Prolonged therapy with multiple antifungals. Eventual resolution with residual corneal scarring -luckily out of field of view-.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038025  

 

I had lasik surgery on both eyes and woke up with terrific vision. My right eye had been -975- so this was a wonderful day for me. Within 4-6 weeks, i had to have my right eye done again, because it slipped back to about -200. Now, 9 years later, i have eye plugs in both eyes because they are so dry, use drops several times per day, and have to wear glasses to see to drive or watch tv. My right eye has slipped back again, and my left eye is blurry. I have also developed sjorgens syndrome- so i don't know how much the dry eye is from that or the lasik.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038029  

 

Had lasik surgery three years ago. Since then, i have bad vision at night, i see halos around bright lights, and star bursts. Vision during the day is great, but at night it is not very good. I also have dry eyes all the time.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038034  

 

Lasik -- i had high myopia -roughly -10 diopters- and large pupils. I did my research, and asked many questions about problems like halos and blurry night vision. I was assured my chances of those problems was low. Sure enough, i still have significant problems with halos and night vision more than 10 years later. And the level of correction "missed" by a significant amount -- 1. 25 on one side, -1. 75 on the other.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038044  

 

Over two years ago i had lasik performed on both my eyes. The dr was thorough in addressing possible hazards and counseled me. I was very near-sited with a serious astigmatism and had worn glasses since 7th grade. Probably needed them well before that. I was better than 20/20 correctable with glasses. After counseling i opted for mono-vision, which would have allowed for book/computer reading in one eye, and distance/driving in the other. The surgery resulted in both eyes being far-sighted. I then underwent 2 - 3 additional corrective surgeries. I am still not satisfied with the results. I cannot file my nails, read most non-computer correspondence/print, properly apply facial cosmetics (eye liner or mascara), etc. Reading glasses do not help with these problems either. Another puzzling complication is that i even have trouble with such mundane tasks as putting away laundry, arranging my closet and dresser drawers, filing personal papers, etc. My eyes tire easily. Prior to the surgery, i could read books, magazines, personal papers (bills, etc), watch tv, etc. All day long with no ill effect. Now i tire within a few hours. This affects my work and earning an income.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038045  

 

Adverse results from lasik. Twenty months after the procedure: blurred vision at all distances, ghost images, halos, starbursts, dry eye, poor contrast sensitivity. Procedure in 2008. Treatment for blepharitis in the next six months. After that, no treatment other than continued use of restasis and intake of fish and flax oil to encourage tear production.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038072  

 

I had lasik to correct near-sightedness, and although i can see well since the surgery, i do have very diminished night vision, very dry eyes, and sometimes have difficulty in focusing on things. This is much more pronounced when my eyes feel dry. If i try to read for any length of time, my eyes dry out a lot, and it's hard to focus on far away objects after that. Before the surgery, i was able to read for hours, and not have this problem. I do wish now, that i had not done the surgery, but it's too late.

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038076  

 

Following lasik surgery, i experienced gradually increasing halos and starburst as well as a general deterioration of night vision. Additionally, i continue to experience "floaters" in my field of vision, particularly on the periphery of vision. Finally, my reading vision has degraded inexplicable ( no significant family history of such at my age). The doctors and technicians explained that halos and starbursts might be a temporary problem but assured me that they would stop and fade shortly after the initial procedure - this was over four years ago. The other problems i encountered were not mentioned to me at all. At this time, i am limited in my night driving as a result and forced to employ strong reading glasses in my professional life in order to maintain basic clarity when reading. The facility i used was vision center.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038078  

 

I had lasik surgery to correct nearsightedness in 2004. I have since developed halos and starbursts at night, affecting my vision and my ability to drive. I was given prescription glasses which do not really correct the halos and i cannot drive in the rain.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038080  

 

Lasik procedure was done in 2007. Ok for a couple of days, then eyesight got progressively worse. Many follow-up treatments, later an "enhancement" was done to one eye. Eyesight has gotten progressively worse with that treatment also. Now they are considering doing a third treatment in a couple more months. Thousands of dollars spent and little improvement to vision.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038083  

 

In 1999, i went in to have lasik eye surgery laser center. The doctor cut a deep flap on the first eye. He then went on to laser and penetrated into my anterior chamber and then aborted surgery. He never did the second eye. I went in with -7. 00 diopters in both eyes and came out with a -22. 00 in my right eye. My doctor was disciplined by the bme in 2006. My present doctors recommend that i have a cornea transplant.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037585  

 

It is still too early for me to definitively evaluate my "advanced" -maybe it's called wavefront?- lasik, since the eye doctor tells me that it takes several months to stabilize. I'm trying to be patient, but i'm still waiting. I have severe myopia, and the surgery did seem to improve my vision greatly in that regard. I can read road signs, if the print is large enough, without glasses now, whereas before i would not be able to recognize a person's features if their face was 3 feet away. However, my vision is blurry, and i suspect that is a bit of astigmatism that hopefully can still be corrected if i am allowed to go in for a follow up procedure. The halos around lights at night have subsided but are not totally gone. I am unable to focus a camera perfectly through the viewfinder. I hope that i can have a correction made, but if not i am going to have to ask to get glasses and hope that my vision will be clearer. I did not go into this procedure with unrealistic expectations. At best, i was hoping that i would have incredibly clear vision, like a celebrity in the promotional posters must have, because i know he would not settle for "close enough. " at worst, i was hoping that at least i could function if i lost my glasses, and this is the case. However, i do feel that people should be very careful about what they think will happen after lasik. So far i have not had any complications other than dry eyes, but it is still too early to tell about that either. Now that i talk to my friends who raved about the surgery that they had done years ago, i find out that their vision is not perfect either, but they don't seem too concerned about that. People need to know that it is a complex surgery and to get things perfect is not guaranteed. They either need to read the fine print, with their glasses, or the doctors need to be more honest and spend more time with the pt to make sure they understand all of the details. I am in the midst of several follow up exams at my optometrist. He has pronounced my vision to be 20/20, although i am telling him that my vision is still blurry. He tells me that the eyes are still healing on the cellular level, and that they are dry. I am waiting before i can fully evaluate the effectiveness of the procedure, but it has been several months and i still do not have perfect vision. I do need reading glasses, but at the age of 50 i was expecting this. It is my far distance vision that i am concerned about. Tlc laser eye center, lansing, mi.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037588  

 

Had lasik surgery and had 20/20 vision for the first year or so. Nighttime vision has been increasingly difficult, starbursts around lights has been constant, and overall daytime vision is now around 20/50 after 7 years -failed the eye test 4 years after surgery. Eyes take longer to focus and adjust on objects. I have had to wear glasses or contacts for driving, sports, and most outdoor activities. Overall, i am not happy with the adverse effects that have been happening since i had the surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037589  

 

Experiencing starbursts and halos when looking at light sources after having lasik eye surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037590  

 

Lasik surgery. I've had 5 different lasik surgeries. I was not pleased with the information given to me. Need for reading glasses. They did not effectively warn me about the acceleration of the need for reading glasses, due to the surgery. I did not need any type of bifocal lenses prior to the surgery. They corrected my vision, so that one eye was designed to read up close and one to see far. This causes all kinds of frustrating problems. I ultimately had more surgeries to correct this and chose to start using reading glasses rather than have the constant strain on one eye, or the other. Need for repeat surgeries. I was also told that, once corrected, i would never need another surgery. I was fine for about 2 years, but then my vision started to decline again. I had another surgery to correct one eye a year ago, and the other eye is now over 20/50 again. I had purchased a life-time adjustment plan on the original surgery. When i called to get the other eye corrected again, they informed me that they no longer support the life-time plan and i would have to pay another $ to correct my bad eye. They have obviously figured out that the surgery doesn't last, and it is costing them money.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037591  

 

Had lasik on both eyes. Right eye - my dominant eye was still slightly blurry at a distance. Wanted distance vision corrected, even if this meant wearing reading glasses. Doctor re-treated 3 months after initial treatment with another lasik procedure. After the second treatment, my eye was much worse. Right eye is now at 20/100. I see 5 or 6 of everything with that eye, and cannot see anything, but a blur at night. Doctors proclaimed the procedure a success due to the fact that with both eyes open i could see 20/20. Suffer from dry eyes, but i am able to treat this with otc drops.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037592  

 

I first had lasik eye surgery on both eyes in 2003. Within a year after the surgery, my left eye had worsened from 20/20 to where i needed corrective glasses. I went ahead and had the surgery over again in that eye only. Now my left eye sees very well. However, my right eye has over the years begun to get blurry, to where i can no longer see street signs with that eye until i am right under them, and i have trouble reading very large power point presentations. My right eye is very blurry and it causes headaches because my eyes have such different vision. I have resisted going back to the eye doctor for the fear that they will tell me i need to have yet another surgery, or get glasses. It's gotten to where i am not comfortable driving at night, so i am going to get glasses. Since my original surgery, i have read that lasik shouldn't be done on eyes that are potentially still changing. I wonder if that's what happened in my case, since i was only 23 when i first had the surgery. Either way, i am not totally dissatisfied with the procedure, because it is certainly better than before, but i wouldn't say i am completely satisfied, and i am scared of what may continue to happen to my vision in the future

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037594  

 

After i have lasik surgery, i now have starburst when i see lights at night, more so in my left eye, then my right. My night vision is not as good as it used to be. I have the ghosting effect, double images when i am in the dark looking at something that is in the light. From the audience looking at a stage. I have a hard time reading now because of my left eye and the ghosting effect. Things in my left eye are bigger and blurrier than in my right eye. All of these side effects are there even though i technically have 20/20 vision now. I would have preferred to wear contacts for the rest of my life and be able to read than have 20/20 vison and not able to read.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037599  

 

Lasik surgery to both eyes. Procedure was to create "mono-vison" with left eye for distance vision, and right eye for near vision. Initial surgery failed as right eye healed with a focal distance of approx 8 inches instead of the desired 24 inches. After three months for the initial surgery to heal, a second procedure was performed to correct the right eye. This procedure also failed, as the right eye now had a focal distance, approx 30 inches. The surgery center suggested solution was to alter the left eye, which had headed properly following the first procedure. I declined, not wanting to risk my vision any further. The initial assessment was performed by a technician and an optometrist. I did not see the surgeon until just minutes before the procedure. To this day i require eye drops several times a day - a possibility that was not impressed upon me prior to the surgery. After 21 months, i gave up squinting in order to read and returned to glasses. I now wear tri-focals. I believe the decline of my near vision, which was fine before the surgery, was hastened by the surgery. I would not recommend this surgery to anyone.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037601  

 

Approximately, ten years ago i had lasik surgery. After the surgery, i experienced halos and starbursts around lights at night and double vision at night such that headlights and street lights were double. This problem has improved over the years, but, i still have problems at night with lights - milder halos and starbursts. If i had a choice now, i would not have lasik surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037603  

 

Had lasik with customvue on both eyes. Vision is now good, but sometimes unstable esp towards latter part of the day. On-going problems include: dry eye problems and floaters which occurred as a result of the procedure. The dry eye problem has been mostly taken care of by daily eye drops and punctal plugs.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037638  

 

I had lasik surgery - ladarvision 4000, with intralase at eye institute. Since then, i have had starburts at night, severe and painful dry eye, and increased floaters.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037644  

 

Pt had lasik surgery at facility by dr. In 1999, on his left eye. Subsequent to, and as a direct result, of this surgery the pt acquired chronic impaired night vision - starburst, glare, and halos. Additionally, he has dramatically reduced contrast sensitivity. This was confirmed on a contrast sensitivity test in 2000, where his left eye scored 50% but his right eye - unoperated - 100%. Because of the devastating negative outcome the patient decided against the planned lasik surgery on the right eye. The disparity in the visual acuity of his eyes resulted in a secondary condition of anisometropia and he is now dependent upon a contact lens in his unaltered right eye as his only means of balanced, corrected vision. As to a cause of the negative outcome it became clear to the patient after second and third medical opinions that his left pupil size was large and made him a poor candidate for lasik - 6mm ablation zone and patient has 8mm to 9mm pupils on low light. Facility incorrectly assessed his pupil size at 6mm in low light. The patient recalls that his screening by a technician at facility was done only using a card with varying sizes of black circles. He now has learned this to be the most primitive of techniques in assessing pupil size and there is also no standard for pupil measurement - whether devices or techniques - in the u. S. He is also dismayed that dr. Did not independently verify his pupil size at any point prior to surgery. There is apparently no surgical recourse for this outcome of poor night vision, anisometropia and loss of contrast sensitivity, none of which were disclosed in his consent form for the off label use of the summit laser for lasik. In 1999. Lasik surgery performed by dr. At facility, affiliated with another facility-. Dates of use: one day in 1999. Diagnosis or reason for use: correct lasik refractive eye surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037656  

 

I had lasik surgery in late 2003 by a dr. It was traditional lasik using a b & l technolas laser. The outcome was not as i expected. I share the blame as i signed a document that i fully understood the risks of the surgery. I only did so after being assured, by the physician himself, that i was an excellent candidate and would love the results and that the possibility of complications were extremely small. I was never told about dry eyes, complications of night vision, possibility of ectasia, etc. Needless to say, i feel as though, i was swindled by a very good salesman. I was a -3 to begin with and regressed to a -1 following the surgery. I still struggle with dry eyes today, over three years following the surgery. I have difficulty driving at night because of the halo effect of oncoming traffic lights. I would urge the fda, to put some type of procedure in place that would let the general public know that some individuals wished they never had the surgery. Perhaps have them watch a mandatory dvd of people who have had bad experiences. I think this should be part of the sales pitch that the doctors make when trying to get patients to come to their establishment for the procedure. It's too easy to have the procedure, especially when something as vital as your eye sight is on the line.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037657  

 

I had custom intralase lasik in 2007. My vision in my left eye was 20/40 after surgery. I had an enhancement done in seven months later on my left eye. Several weeks after enhancement, i noticed floaters in both eyes but especially in my left eye. These have not improved in the 6 months or so after my enhancement. These floaters consume most of my waking thoughts. I have researched for hours to find out there is nothing that can be done about them. They have caused me enormous stress and depression. I have a hard time with the thought that i will have to live with these forever. When i had the surgery, there was never any mention of floaters in the papers that i signed. I realize i took a risk having surgery, but is it possible that a study could be done to determine if floaters are indeed caused by lasik? there are so many people that have floaters that are struggling to cope with this garbage in their eyes. I know it is not a life threatening condition but i know that quality of life is definitely diminished. Please take this seriously. I would go back to my glasses days in a heartbeat ! !.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037658  

 

After "all-laser" lasik with wavefront, i am experiencing vertically-stacked double images in both eyes due to astigmatism introduced by the surgery, see halos and flares at night, and i have a corrected vision level of 20/40.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037659  

 

In 2003, i underwent bilateral lasik using the visx customvue platform following the screening by and recommendation of a dr of eye center. I was informed that i was an excellent candidate for the procedure and inquiries as to whether pupil size and/or size of correction were potential adverse considerations in the determination of my candidacy, such concerns were very cursorily and flippantly dismissed and the customvue technology was purported to eliminate the adverse consequences experienced by some, prior lasik procedures - with advertisements showing pictures of rep visual outcomes with and without customvue technology. The result of the procedure was the immediate inducement of visual smearing - far worse than anything ever seen in even the poor outcome representations that customvue was to render obsolete - upon expansion of pupils in indoor, dim lighting and nighttime settings, a directional smearing and loss of contrast sensitivity due to the cumulative effects of such smearing. In inquiries immediately following the surgery, dr alleged that the visual smearing - very precisely and accurately described by me - could potentially be the result of brain / optic nerve issues that would necessitate visiting a neuroophthalmologist that could potentially be extremely serious - and, of course, of no relation to lasik. I visited a neuroophthalmologist who concluded the results to be caused by lasik and that i had extremely dry-eyes. Dr would later cite psychological problems and the need to seek therapy-. The cause of the induced problems were very clear and obvious to those with even a casual understanding of the subject - and even the tiniest degree of honesty, integrity or compassion for human beings-: the ablations were systematically decentered superiorally which, when coupled with inadequacy of optic zone for size of pupils (note: pupils were noted at "16. 0mm" with lights off by pre-qualifying examiner - dr of another place- despite being extremely large even to the casual observer - registering at 8. 0mm by physicians in subsequent visitations; as such, qualifying/referring practitioner likely set the pupil size equal to the size of the treatment zone so as to conclude one to be a good candidate, not because it is actually the size of my pupils and amount of tissue removed, accounted for all of the visual problems experienced. This is very clearly evidenced by all topographies; this was not the product a biomechanical instability of the flap manifesting itself as an undesirable healing pattern but by an incorrect alignment as achieved by the laser platform and the practicing physician, which is supported by artemis scans and the immediacy of symptomatic descriptions. The flagrant lies following the procedure caused tremendous mental/psychological distress - i am not a complete idiot, so i had a sense that i was being lied to by first dr and assorted referring physicians concerning the cause and prognoses of the devastating and life-altering results - due to the fact that i soon realized i could not obtain the truth concerning my current condition from anyone in the industry - i visited many throughout the country - due to their interests in protecting their colleagues and their profession. What i encountered during my efforts to work with the medical community - the willingness to do and perpetuate harm at any cost for - albeit tremendous - personal gain; greed manifested by a desire to perpetuate a practice at any cost and any level of dishonesty and obfuscation in the midst of those literally crying for help or at least acknowledgement of problems induced if help was not possible - beyond any description - was something i will never forget. I obtained confirmation of the truth of what was done to me only upon traveling overseas - to london, england - a tremendously painful and difficult trip given the dry-eye and visual disruptions - apparently severing the code of silence on my travel across the pond. Perhaps even more importantly, the lies perpetuated by the lasik community during my inquiries immediately following the surgery very likely caused a further life-long devastating condition: dry-eye. First dr prescribed alphagan p approx 10 days post-op - without the disclosure of its potentially devastating dry-eye effects if applied to recently ablated eyes during a crucial time/window when corneal nerve regeneration is of utmost importance - due to the devastating visual effects - and election not to disclose the reason for the directional smearing and consequent ineffectiveness and inadvisability of pupil-constricting medication as a post-op, long-term solution given the cause-; he then prescribed c-pilocarpine due to lack of efficacy. Dr holzman then prescribed - within approx 2 months of the surgery - corneal gas permeable lenses; the practitioner to whom he referred me had no experience fitting such lenses in post-lasik cases. The pain of lens wear was truly excruciating. All of these courses of actions prescribed likely retarded corneal nerve regeneration during the time period in which such regeneration is crucial, resulting in the -extreme, irreversible- symptomatic onset of dry-eye pain, which progressively worsened to a constant and debilitating state.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037660  

 

I had lasik surgery in 1998 and following, have post lasik ectasia in both eyes. My vision has progressed to the point where my left eye is legally blind, and i function using my right eye, which gives me 20/60 vision but with severe astigmatism, so i have constant disabling headaches. I also wear an eye patch on my left eye because my brain cannot process the images produced by the eyes at the same time - anisometropia - without getting even more severe, intolerable headaches. Because of the constant headaches and low vision, i cannot work or attend school and i do not qualify for disability. The surgery - performed, using a visx laser - has absolutely ruined my life. I am not a good candidate for a cornea transplant because i have extremely dry eye, also exacerbated by lasik surgery. This surgery has destroyed my life. Please contact me if you want further info.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037661  

 

I received bilateral lasik surgery with the visx inc. Star excimer laser system and have had significant ongoing vision problems post-op. I had no surgical complications (flap problems, infection, etc). However, i have significant higher - order abberations, resulting in poor vision acuity and quality and double vision (daytime and night), and glare - especially at night. My best corrected vision with lens and/or spectacles is much poorer compared to pre-surgery.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037662  

 

Surgeon cut a short flap during lasik procedure and did not abort procedure. Eye was lasered in only one half of intended area, and the underside of the flap was also lasered, resulting in a severe permanent scar in the field of vision.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037663  

 

I need contacts for both eyes, but i had lasik on my right eye only due to my flexible spending account situation. I now have a harder time seeing out of that eye at night because of the starbursting that was supposed to go away after i stopped using the medicated eyedrops. The doctor told me it would be a day or two after i stopped using the eyedrops that my starbursting would go away. It has now been three weeks since surgery, and there is no improvement with the starbursting. My left eye still sees normally at night when i wear my contact. My right eye vision has been corrected, but i notice smaller starbursts during the day and big starbursts at night. I was planning to have the left eye done as well, but i don't want to do it until i know my right eye night vision improves. I might be part of the 5% who experience permanent starbursting after the surgery since the effect is taking longer to go away than the doctor expected. I have a true before and after comparison and i am not yet satisfied with the results.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037785  

 

I have had three lasik surgeries to correct my vision. At no time did i ever achieve the "20/20" ideal. My eyes keep regressing. After the first surgery, they poo-poo'd me and told me to use more eye drops. I thought this was absurd as i was not going to use eye drops every few mins just to see, and my eyes did not feel dry. Since the first, i have had bilateral lasik and a third in just one eye. Within one year of the final surgery, i was back in glasses to see. I was now in bifocals, which was not needed before. I heard the article on npr radio this morning. If this is the info you need, i will be happy to research my records for more detail.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037786  

 

Received lasik eye surgery on my right eye. Prior to my appointment i had many scans from the tlc ctr on my right eye. I had all the required pre-op appointments. The day of my surgery, the doctor put the ring around my eye. The device was off ctr and had to be adjusted and put back on. My eye ball swelled and i had a large red ring where the device was. The lasik was performed. Outcome was good. Two months later, i awoke to great pain in my right eye. Later that morning, i noticed that i was missing vision from the ctr of my eye up. I was like someone pulled a shade over half my eye. I went to the eye doctor for my follow up visit, and i mentioned this new development. My retina detached. I had to see a specialist for a scleral buckle. This reattached my retina. However, i no longer have 20/20 vision in my right eye. I was told they can reperform the lasik to recorrect my vision. After all that, i went through i do not think i will have it redone. I have since gone into a deep depression and now i am being treated for that. I still have to see the retinal specialist for check up. I have very poor night vision in my right eye. In the paper work, i signed for the surgery for lasik procedure it did say that there was a possibility of detached retina, however, i did not understand what that meant.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037787  

 

I don't remember the exact date, but it was sometime in summer of 2000. I had lasik surgery and i'm semi-unhappy. Vision is not as good now as i had hoped it would remain, even though it was about 20/15 for some time after the surgery. Severe dry eyes and halo effect, uncomfortable at times with night vision/driving. Surgical results still better than contacts were for me, but overall wish i had stuck with glasses, i think. I continue to use restasis eye drops for dry eyes and experience much discomfort most mornings wear glasses to bring vision back up to 20/20. Must have 20/20 for my job.

 

 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037788  

 

Re: lasik surgery - adverse outcome. I understand the fda is investigating lasik surgery and is soliciting feedback from consumers who have had poor outcomes. I am reporting an adverse result. Here's my story: had the procedure done in 1999. The procedure was a failure from day one. I never fully corrected my vision and has deteriorated ever since. Initially after the procedure, i got by without glasses or contacts, but it was a real struggle to see. I then had to very regrettably go back to contacts, but had to wear soft "toric" lenses which i had never had to wear before. I had some astigmatism pre-op but, the lasik made it even worse. In the past two yrs, i have become fully contact lens intolerant. They do not correct my vision, they actually horribly distort it. I have tried many different types, including "hybrid" lenses for post surgical patients. I must now wear glasses 100% to see. My corneas are severely distorted and i have a bulging thin spot at the bottom which precludes any further procedures. I am not correctable to 20/20 with glasses, so bottom line, lasik has been an absolute disaster for me. I have gone for multiple opinions and have been diagnosed as having lasik ectasia, keratoconus, pellucid marginal degeneration, pmd, and "we don't know why it didn't work. " i was told that i should never have had the surgery looking at my pre-op topographies today, but i had gone for 3 evals before doing the surgery and no one had expressed any concerns or that i wasn't a "candidate. " so on top of having an extremely poor outcome, my other complaints are dry eye, and lots of junk in my vision, floaters and flashes. It has also been pretty devastating emotionally to hear all the glowing lasik stories, while i now have fewer corrective options than i did before the surgery, my bcva isn't event 20/20. There are also the time and personal expense issues of flying to see specialists, going to multiple appointments and the absurdly expensive treatments, intacs, c3r and special lenses that don't even work.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037789  

 

Underwent lasik procedure; unfortunately have redeveloped vision deficit and halo with difficulty with night vision especially while driving; now using contact lenses again but with less myopia than before.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037790  

 

I am glad to know fda is looking at lasik side effects. I feel i gained more from the surgery than i lost and i never filed a complaint with my doctor. I thought i was informed of all the risks, but i think things were not known at the time. While i had 20/20 vision for several years and the initial results were very dramatic, my eyesight has worsened over time. I began wearing slightly corrective glasses in 2002. Now i wear glasses most of the time. It isn't absolutely necessary in the daytime, but since my vision is not perfect, so it helps me, esp. With my weaker eye. It went back to being the weaker eye. More seriously is the fact that my night vision is seriously impaired. I cannot drive without my glasses at night. I do fine in the city where there is a lot of light at night. And, rarely found myself driving in darker places. But, i discovered a couple of years ago that i cannot drive in areas where it is darker and single lights serve the purpose of lighting. Single highway lamps or other cars headlights completely disperse and obstruct my vision. The light bursts out in lines in many directions. Seriously, i will not drive at night under those circumstances.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037796  

 

Following lasik surgery, my eyes no longer produce natural tears. To control the extreme dryness, use eyedrops throughout the day. I also need to wake up throughout the night to use the eyedrops; typically eight times per night. I use one large bottle of eyedrops per week. In the two years following the surgery, i also have experienced frequent headaches and frequent eye infections.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037797  

 

I had lasik surgery and was promised 20/20 vision with no need for glasses. Two yrs later, i still experience dry eyes, need for nearly constant wear of closeup glasses for 1st 10 feet, and fuzzy night vision. I am a physician and waited to have the surgery and only let myself do it because, it was explained to me that all the kinks were worked out of the procedure. I am able to see distance without glasses, but if i was clearly explained the downsides which i experience i would have waited more yrs for further improvement in the procedure. Unfortunately, medicine in this country has become big, maybe biggest, business and doctors, medical industry, hospitals are not under any real self, government, or fda ethical, moral quality control, in my field of orthopedics millions of unnecessary mris, xrays, procedure, surgeries and labelin


 

Site Map

LASIK