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-$4,000,000.Million Dollar Lasik Case Won by Steven Post. (Ex United Airlines Pilot)...
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A Complaint With The Department of Regulation in Chicago -FDA Approved Lasers which doesn't mean much coming from our dear old FDA...
-James Oreilly's Calls "Eye For Eye"
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an honest letter written by an EX-Lasik Doctor describing the
Lasik Procedure & known damages...
An alarming 35+% of eyeballs that had Lasik have many of the following systems & 60% of all of the people I have asked about their Lasik Procedure told me that they had "dry eye syndrome" or that their "nighttime vision is terrible along with the following:"
-Loss of Contrast/Detail.
The only Laser Platform
out there that you should inquire about doing to your only set of
eyeballs may entail the following technology in order to get better:
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May God bless their eyes for a
cure, may God help them to win their lawsuits
against Nick Caro Family,
may God help each of these families in coping with the
"aftermath," & may God make Nick Caro
& Family
pay for their "innocent" sufferings:
Attn: Investigator Dan Murphy/Dr.
Larry McClain: |
 January 4, 2007 Food and Drug Administration Dockets Management Branch IMMEIDATE PETITION REGARDING LASIK/REUSING MICROKERATOME BLADES Room 1-23 12420 Parklawn Drive Rockville, MD 20857 w: (301) 827-6860 Petition Submission RE: Lasik is still not safe, creating an unpredictable flap that never heals, how doctors are NOT telling the public/patients this, and how doctors are re-using blades to cut the flap creating multiple layers of problems and then trying to sue innocent patients like myself when we have websites like www.LifeAfterLasik.com that tells the public the truths about Lasik, and about doctors such as Nicholas Caro who has over 50++ lawsuits but is still somehow practicing “slicing and dicing” techniques… FDA/Medical Device Committee/Dockets Management Branch: Please immediately take steps to approve the following “Petition” I-VI to insure the safety of Americans regarding the misuses of Lasik going on in America today by refractive surgeons whom are stepping outside the “ethical” limits on many levels regarding “breaching the standard of care” we should all be given. Table of Contents
1. Statement of grounds 1. Statement of grounds: The FDA Needs To Immediately Define & Implement Safety Measures To Improve Lasik Success Rates, Make Sure Refractive Procedures & Surgeons Are Not Breaching The Defined Standard Of Care That Should Be Given To Every Single Patient’s Eyes, & To Work With The AMA & Department of Regulation In Every State To Bring Down A Doctor For Violating “The Hippocratic Oath.”
1.1 Examples of Devices included in the Scope of the Petition:
Each of these medical devices are regulated by the FDA as Class
I or Class III medical devices. All FDA approved lasers,
intra-lasers and microkeratome blades currently in use to make a
flap cut ruining a 1.2 Consistency with FDA’s Goals: The benefits of this petition outweigh the costs by effectively utilizing the limited FDA resources in an area where they are most needed to meet the goals of the FDA, Assuring Medical Product Safety, and protecting the Public Health (http://www.fda.gov/ope/FY03plan/default.htm). The following statements provide the basis for the benefits of this petition. The costs would be based on which agencies and what specific actions are taken based on this petition. “Consumers spend $326 billion annually in the U.S. on medical products. An estimated 1.3 million people are accidentally injured by medical therapy in the U.S. each year, and as many as 100,000 die as a result of preventable medical errors. FDA must be vigilant in monitoring the production, distribution and use of these products because FDA's presence raises the likelihood that public health and safety problems associated with these products will be addressed and because it is critical to citizen safety.” “To ensure that these products are safe the Agency must oversee their entire life cycle--from production through distribution, and consumption/use. “ “FDA's three primary strategies for ensuring medical product safety are to: a) enhance global vigilance over product manufacturing and distribution; b) strengthen and focus domestic industry monitoring; and, c) expand and automate the systems which report on adverse events associated with the use of medical products. “ The FDA’s goals are consistent with preventing injury and protecting the Public Health. Has the FDA ignored or even endorsed another potential Public Health Crisis (e.g., breast implants)? “A weakened FDA can only move slowly and with uncertainty. Consumer confidence in the Agency suffers, and real health and safety risks may grow.” http://www.fda.gov/ope/fy03plan/goals3.html * Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.“ (http://www.fda.gov/ope/fy03plan/goals.html) 1.3 Legal Basis for this Petition: The Petitioner makes a public demand that the Food and Drug Administration (the leading U.S. public health regulatory agency) assert its authority and supremacy in protecting the Public Health. The Petitioner acknowledges that the FDA does NOT regulate the practice of medicine. The Petitioner further acknowledges that an "off-label" use of any device where benefits clearly outweigh risks may constitute the practice of medicine. However, practice of medicine does not allow anyone, including medical doctors, to break Federal or State laws. Furthermore, any user of these Class I devices (whether licensed physician or not) who violates the labeling of these devices unnecessarily exposing patients to a non-Prudent degree of risk, does not provide informed consent, and therefore, is not practicing medicine by definition. Thus, these practices are within the regulatory authority of the FDA. The Petitioner asserts that when used in LASIK surgery, every patient MUST receive new Microkeratome components (e.g., blades and cannulas), regardless of whether the device is operated by a physician, or a technician working under the supervision of a physician. Microkeratome components necessarily come into contact with blood and infectious corneal tissues. As such, their reuse is not practice of medicine, or even within the Standard of Care for any licensed physician, for any medical procedure, including LASIK. Moreover, if sterilization of Microkeratome blades and components is not performed at all, or is conducted by third parties whose motives are mainly economic (not necessarily medical) then this also falls under the authority of the FDA. Finally, sterilization techniques commonly used (when they are used) are not effective with regard to HIV/Aids and other infectious diseases (let alone Creutzfeldt-Jakob Disease prions), historically an overriding public health concern which requires these components be used once and only once, then disposed of as hazardous medical waste. Accordingly, the Petitioner concludes that there is NO patient benefit for reuse of these device components, but instead, a very high potential for harm. There are multiple additional legal bases for this petition because the Microkeratomes are regulated by the FDA as Class I medical devices for use in refractive eye surgery (commonly referred to as LASIK). 1.3.1 In general, the reuse or reprocessing of single use devices on multiple patients is a serious concern (see http://reform.house.gov/UploadedFiles/121605%20FDA%20Medical%20Device%20Letters.pdf). Reuse also appears to be an off-label use or even violation of the FDA approval. Worse yet, the patients are exposed to the contaminated blades without resterilization. I think patients should be properly educated and informed prior to having LASIK surgery. In light of present day Medical ethics, patients should be given true informed consent by a licensed medical professional (e.g., the M.D. Ophthalmologist surgeon explaining the true risks to physical and mental health). Unlicensed sales people who may be dressed to look as if they are medical professionals (e.g., wearing white lab coats) should not be allowed to explain things as their information may be incorrect and they may mislead patients. Reusing a microkeratome blade used on another patient is not prudent and far too risky for patients. No patient should be subjected to a reused medical device that is labeled single use, and disposable even if the patient has informed consent. Reusing blades without patient informed consent violates many medical ethical principles including HHS IRB guidelines (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm), The Declaration of Helsinki "It is the mission of the physician to safeguard the health of the people" (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j6 ), the Belmont Report "Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. " (see http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm ) and the THE NUREMBERG CODE "The voluntary consent of the human subject is absolutely essential." "The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury." (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j5). 1.3.2 The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices. Not everything that a medical Doctor does is considered the practice of medicine. Being a licensed medical Doctor does Not allow a person to break Federal or State laws. An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine. However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition. Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor. Any practitioner or user of these Class I devices (whether or Not he/she happens to be Doctor) who uses them in an unnecessarily risky way (including committing an assault) or who does Not provide informed patient consent would be under the FDA’s regulatory authority. 1.3.3 The Petitioner believes that the potential risks versus possible benefits assessment favor the Actions proposed in this petition and are consistent with the FDAs own objectives including Healthy People 2010. “The PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity announced in January 2000 to eliminate health disparities and improve years and quality of life.” (http://www.fda.gov/OHRMS/DOCKETS/98fr/062502c.pdf). 1.3.4 Section 522(a) states that “ In General.--The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class I device the failure of which would be reasonably likely to have serious adverse health consequences” (http://www.fda.gov/cder/guidance/105-115.htm#SEC.%20212). The FDA authority to protect the Public from injury and the Public Health in general is based on section 522 (21 U.S.C. 360l). The CDRH has recorded that the failure of these devices has caused serious adverse health consequences ... 1.3.5 Under the FDA’s authority with the Federal Food Drug and Cosmetic Act and all rules and regulations promulgated or annexed therein, including, but not limited to section 515(d) (g), 520(e) (q) and (r), 21 CFR 801.109, 21 CFR 803.5, 21 CFR 803.10, 21 CFR 814.82, 21 CFR 814.84, 21 CFR 814.39, and the FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997, the Petitioner ask the FDA to act and to implement the enclosed Actions. 1.3.6 Title 21 et seq., Title 45 et seq., and the Good Manufacturing Practices act, and other Federal Laws may have been violated by the practitioners who used these devices. 1.3.7 FDA regulations state that the FDA may require the submission of the adverse safety and effectiveness data, as described in the Class I summary or citation under title 21 Parts 800 to 898, Sec. 807.94, Sec. 807.100, section 515, and other Acts (http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm). (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807). Many adverse events are Not reported. 1.3.8 The FDA is mandated to assure Medical Product Safety. “To ensure that these products are safe the Agency must oversee their entire life cycle--from production through distribution, and consumption/use“ (http://www.fda.gov/ope/fy03plan/goals3.html). The FDA does consider petitions (http://www.fda.gov/opacom/backgrounders/voice.html) and comments for the development of future policy (http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm) and has authority to change that policy under Title 21 Parts 800 to 898, Sec. 807.94, Sec. 807.100, section 515, and other Acts (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=807.100). 1.3.9 The American Academy of Ophthalmology has supported banning a device (bottle rockets) that since 1995 due to it causing eye injuries similar to those caused by elective refractive eye surgery. From July 1990 to December 1994, for instance the total number of serious eye injuries from all causes reported to the United States Eye Injury Registry (USEIR) was 4,575 cases (Serious Eye Injuries Associated With Fireworks- United States, 1990-1994 MMWR Vol. 44/No. 24, June 23, 1995, pp. 449-52; Center for Disease Control MMWR journal). On average over that 4 ½ year time period, that amounts to ~1,017 eye injuries per annum. Based on public information that over a million LASIK operations alone are performed every year and the percentage of those operations causing serious eye problems, the number of serious eye injuries per annum of elective eye surgery far exceeds all other causes. 1.3.10 The Federal Government CAN enforce Federal law even when licensed Doctors violate it. The physicians can use each microkeratome blade ONLY once (one eye only) because Bausch & Lomb (and other microkeratome manufacturers) ONLY license the physician for a single-use only procedure. Only physicians are licensed to purchase this device under Federal law so any other use by the physician would be a violation of that same Federal Law. 2. Reasons for This Petition: The evidence indicates that the users of these FDA “regulated” devices (the users and Doctors/practitioners) do Not use these Class I and Class III medical devices prudently and took a non-Prudent degree of risks with patients physical and mental health.
3. Action requested:
What rule, order, or other administrative action does the
petitioner want FDA to issue, amend or revoke? The Petitioner
is willing to work with the FDA and any other Federal agencies
in assisting with further development of the implementation of
any injury prevention efforts including, but not limited to the
following actions.
4.1 Superior
Technologies Needed To Fix Thousands Of Suffering Patients That
Had BAD Lasik:
Refractive surgeons should be required by the FDA to maintain
“FDA Approved” refractive technologies: Lasers, Topographers,
Wavefront Devices, Slit Lamps, Micro Keratome Blades, etc...Only
superior technologies should be allowed, and any older
techologies or lasers that have been proven to have
“considerable problems,” should be immediately seized by the FDA
and discarded so that no other 3rd world countries
get a hold of “inferior medical devices.” The future of Lasik
should be “no Lasik,” and only PRK technologies that are in the
best safety and interests of the patients, such technologies
exist overseas but not here in the USA:
The following is probably the “best known”
software & hardware technologies for performing Lasik, PRK,
Lasek, but is NOT available in the USA: “Using the confocal scanning microscope, Dr. Bourne and colleagues measured the length of the subbasal nerves per area of field. Between three and six scans of the central cornea, covering slightly different areas of the cornea, will yield distinct samples and allow estimations of the nerve density. Dr. Bourne described two clinical research studies using these technologies. In the first, a 5-year longitudinal study, he and his colleagues studied the effect of PRK and LASIK on corneal morphology by comparing the corneal nerves preoperatively and postoperatively. "With PRK," he explained, "the epithelium is removed and Bowman's layer and the anterior stroma are ablated. After the procedure, the epithelium and the nerves heal over the stromal surface. In LASIK, the stroma is ablated behind the flap, leaving Bowman's layer intact. Most of the nerves are cut when the flap is created, and they must eventually return anterior to Bowman's layer," Dr. Bourne explained.
Dr. Bourne and his colleagues found that after PRK, the nerve
densities decrease and gradually increase; by 2 years after PRK
there is no significant difference in nerve density from
preoperatively. After LASIK, the nerve density also decreases
and returns much more slowly; 3 years after surgery, there is
still a significant difference from the preoperative density,
but by 5 years after surgery there is no significant difference
from preoperatively…” What changed between 2003 and 2005/6?
>Brian S. Boxer Wachler, MD, co-author of the study and a
faculty member at the UCLA Medical Center, Jules Stein Eye
Institute, said, "We know that corneal aberrations and night
vision disturbances after LASIK are directly proportional to the
degree of nearsightedness corrected and the size of the
clearance zone – that is, the difference between pupil size and
the optical zone treated by the laser. With this study, we now
know use of large optical zones is safe and effective in
preventing nighttime glare and haloes in patients with large
pupils." http://www.LasikMemorial.com Dedicated to those whose lives have been damaged or destroyed by refractive surgery, this site contains true stories written by the victims themselves. When complications occur, your life splits in two. There is the person you were before LASIK, and the person you are now...the person whose dry eyes hurt all the time, the person who sees multiple images of everything, who can't drive at night, who can't fulfill his or her responsibilities as a parent, or his or her potential as a human being, the person who suffers from PTSD, depression, and various states of dread about the future. You realize that maybe human nature isn't fundamentally good, or at least that doctors aren't what you thought they were.http://www.LaserMyEye.org Started by United Kingdom refractive surgery activist Rebecca Petris, this site offers both great content and great web design. Don't miss the D'ialogues forum, where you can ask frank questions about risk and receive input from both patients and optometrists. Also has an encyclopedia of terms relevant to refractive surgery, as well as breaking news articles.http://www.SurgicalEyes.org From the site, "The purpose of the Surgical Eyes Foundation is to empower past, present and future patients who live with complications of refractive surgery. Towards this end, it will maintain a website as a primary resource for those with complications of refractive surgery to accomplish the following: 1. Coordinating with eye care professionals to facilitate understanding of the needs of those with complications from refractive surgery and advocating for treatment alternatives. 2. Increasing public awareness of the potential risks in refractive surgery and advocating for informed decision making 3. Disseminating information about typical and emerging treatments to individuals with complications of refractive surgery.http://www.FlawedLasik.com Created by patient activist Dominic Morgan, this site chronicles Dominic's legal struggle with his surgeon and with the FDA. The site states, "Most Lasik websites are advertisements for having Lasik eye surgery. This website is to educate you to the dangers of having Lasik when you are not a proper candidate. Before you consider Lasik, you must be sure it can be done safely, and that you are a proper candidate. I went to a doctor who advertised that anyone who was nearsighted, farsighted, or had astigmatism could be done safely...that's almost everybody! I trusted these doctors, and now I'm legally blind. My name is Dom Morgan, and I tell my story because it may be useful to anyone considering Lasik.http://www.LasikFraud.com Created by patient activist Brent Hanson, this site states, "Are you planning to have laser eye surgery at TLC? Are you impressed with TLC's success stories? Do you believe that TLC will honor their "Lifetime Commitment" to you? Do you have confidence in the integrity and surgical skill of TLC's founder, Dr. Jeffery Machat? If you answered yes to any of these four questions, then please read about my experiences with eye surgery at TLC. Your decision to have eye surgery may result in permanently damaging results that are devastating to you. You may also discover that TLC will not back up their "Lifetime Commitment Program" if they damage your vision. I am going to share my personal story with you so that you can get a more realistic view of what your experience could be like. This story is unpleasant for me to tell, but you deserve to know that TLC personnel are fully capable of damaging your vision, deceiving you, abandoning you as a patient, harassing you, and threatening you with lawsuits for speaking out.http://www.DoctorMyEye.com Created by activist Optometrist Ken Minarik, OD, this site states: "The internet is full of websites that are owned by laser companies, clinics and LASIK providers that will tell you all about the good cases and sell you on the “joys” of LASIK. We will leave the pro-arguments to the salesmen. We are here to talk about things that go wrong and the people who can help you when it happens. Bookmark this site, and if you or a loved one are considering LASIK…please read all of our cautions first. If you or a loved one are suffering from LASIK complications…welcome to your online support group. We are here for you."http://www.LifeAfterLasik.com Created by Dean Andrew Kantis, a lasik patient that flew from Florida to Chicago to ensure that the procedure would be given extra detail, and it turns out that just the opposite happened. The doctor, Nick Caro & St George Corrective Vision Center out of Chicago, IL happens to have 50+ lawsuits from disgruntled lasik patients, and for some strange reason, still has an active license to practice in the state of Illinois. Needless to say, Dean started a huge investigation where the www.IDFPR.com is going back 10 years on Nick Caro. Nick Caro is very concerned about the information on this website in that he is a "DEFENDANT" in over 50+ lawsuits, so he started what many are saying is a "frivolous lawsuit" to sue Dean for $2,000,000.00 to try to "quiet" him, and it seems that Nick Caro has a lot of people trying to get "search placement" to try to push our results down, but so far, it has NOT worked and must have set Nick back even more money. it ended up hurting Dr. Caro's reputation even more.http://www.VisionSimulations.com Created by author and psychologist Roger D. Davis, PhD, this site features photorealistic images of the visual aberrations incuded by LASIK and other refractive surgeries, including starbursting, halos, glare, ghosting, blurry vision, and night driving scenes. Also contain numerous animations, as well as simulators that allow patients to approximate and communicate their vision to friends, family, and physicians. If you want help simulating your vision for others, start here.http://www.LasikSucks4U.com Created by patient activist Dominic Morgan, this site chronicles Dominic's legal struggle with his surgeon and with the FDA. The site states, "Most Lasik websites are advertisements for having Lasik eye surgery. This website is to educate you to the dangers of having Lasik when you are not a proper candidate. Before you consider Lasik, you must be sure it can be done safely, and that you are a proper candidate. I went to a doctor who advertised that anyone who was nearsighted, farsighted, or had astigmatism could be done safely...that's almost everybody! I trusted these doctors, and now I'm legally blind. My name is Dom Morgan, and I tell my story because it may be useful to anyone considering Lasik.http://www.LasikLiberty.com (Want to see what the FDA is doing or is NOT doing regarding the FDA's responsibility to Lasik Patients in informing the public, and in establishing a strict "standard of care?" This website was created by Dr. Michael Patterson, who has been suffering with Post Lasik for over 6+ years...and to date, has found no cure for his post lasik challenges.)http://www.DrDoka.com Read the website of a woman's life completely destroyed in June of 2004 from having Lasik Surgery. Elivra Galindo, continues to make it a mission to let others know how bad Lasik is and that she has gone to over 15 doctors and not one of them have been able to help her with her "post lasik dry eye syndrome. In fact, it is so bad that she wants to take her life. As of today, Elvira continues to suffer from this and "sleep deprivation" because her dry eye is that bad.http://www.EyeFreedom.com (get an honest opinions on Lasik by a Dr. who treats hundreds of Post Lasik victims: Dr. Edward Boshnick, Scleral Lenses for Post Lasik problems)http://www.noblur.com (get an honest opinion prior to your Lasik, by a Dr. who treats hundres of Post Lasik victims from all over. Dr. Ken Maller, RGP lenses for Post Lasik problems)http://www.kcfreedom.org or http://www.kcglobal.org/ (Very informative forum and focused on Keratoconus, a cone shaping/bubbling eye disorder).http://www.Lasikdisaster.com (very informative Post Lasik Information)…http://www.LasikInfoCenter.net (very legally informative/has Glare Charts)…http://www.foxchicago.com/_ezpost/data/16747.shtml (Fox Chicago news on how bad Lasik really is to inform you)http://www.lasikfraud.com/ (very informative A-Z of Lasik & problems with Lasik)http://www.fda.gov/cdrh/lasik/contact.htm (FDA file a LASIK complaint)…http://www.visionsimulations.com/ (exactly what to expect to see like after Lasik)http://www.doctormyeye.com (some honest information about Lasik and Post Lasik)http://www.lasikmemorial.com (some honest information about Lasik and Post Lasik)http://www.lasermyeye.org (some honest information about Lasik and Post Lasik)http://www.flawedlasik.com (some honest information about Lasik and Post Lasik)http://www.surgicaleyes.org (patient nightmare stories, good Post Lasik Doctors to help you)http://www.lasikmemorial.com (some honest information about Lasik and Post Lasik)http://www.lasiksos.com (some honest information about Lasik and Post Lasik)http://www.lasiksucks4u.com (some honest information about Lasik and Post Lasik)http://www.lasikreality.com (some honest information about Lasik and Post Lasik)http://www.refractivesource.com (some honest information about Lasik and Post Lasik)http://www.kcsupport.org (make sure your doctor correctly evaluates you before Lasik)http://www.cleareyeclinic.com/lasik.html (clinical results of Lasik, 3 questions to ask, but not the right question)http://www.anattorneyforyou.com/legal/lasik-litigation.htm (list of Lasik Litigation Attorneys to help you)http://www.ophthalmic.hyperguides.com/default.asp?section=body.asp (pain management & other eye problems/treatments)
http://www.crstoday.com/PDF%20Articles/0105/F3_Daya.html
(additional problems Post Lasik)
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