Jeffrey Shuren Called on to Withdraw FDA Approval of LASIK Devices

FDA Lasik Response to FDA Webview Challenged

Reprinted with permission from


LASIK Surgery Watch says it disputes most of FDA’s response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving excimer lasers for LASIK during his tenure (see story).

In a 9/13 letter to CDRH acting director Jeffrey Shuren and other FDA and HHS officials and members of Congress, LASIK Surgery Watch says that FDA caveats that its guidance documents only provide guidance “in no way exonerate [it] for approving excimer laser devices for LASIK, a procedure with complications in excess of 20%.” The group also asserts that no number of subsequent meetings or revisions to the guidance could justify such damage to American eyes.

On the issue of LASIK re-treatments, LASIK Surgery Watch says that while it agrees with FDA that such re-treatments were never approved by the agency, they still are common and speak to the lack of efficacy of the initial LASIK procedure.

LASIK Surgery Watch also questions FDA’s comments on adverse event reporting in its database. The agency’s emphasis that most reports are not recent only demonstrates that damaged patients have no idea where to report adverse events, it says. It also says that FDA statements about adverse events reported in its own database are incorrect. It says the agency mis-reported the number of voluntary adverse event reports and asks why it is providing misleading data to the public on its own adverse event database.

The remainder of the letter reviews for Shuren all of LASIK Surgery Watch’s concerns about the procedure, including citation of a number of medical journal studies. “LASIK is a medically unnecessary surgery that carries with it permanent adverse effects and substantial risk of permanent visual impairment,” it says. “As evidenced, LASIK complications occur frequently. It is reasonable to conclude that LASIK eye surgery has become a leading cause of preventable visual impairment in the United States.”

The letter calls on Shuren to immediately withdraw FDA approval of LASIK devices.

Meanwhile, a Consumer Reports survey has found that 55% of Americans who had LASIK surgery continue to wear glasses or contact lenses at some time. And many of them say they were misled by advertising for the procedure that led them to expect they would not need other eye correction after surgery.

“Laser vision correction surgery is a largely unchecked industry, and consumers need to know the right questions to ask to be sure they’re protected and that they’re getting good quality care for their money,” says Consumer Reports Health Rating Center director John Santa. “Vision correction surgery is increasingly popular but there is a concerning lack of unbiased, concrete evidence about its safety and efficacy.”

Survey results showed that 53% of patients experienced at least one side effect within the first four weeks after surgery, and 22% experienced them six months after surgery, especially dry eyes and visual symptoms like halos, glare, and starbursts around lights.

FDA to Investigate Deceptive, Misleading LASIK Ads

Reprinted with permission from
CDRH to Review 18 ‘Violative’ LASIK Ads

Responding to a complaint by Florida-based LASIK activist Dean Andrew Kantis, CDRH’s Office of Compliance said 9/11 it would give “appropriate review” to 18 Web site advertisements by LASIK surgery firms that Kantis had gathered and sent to office director Timothy A. Ulatowski. Founder of the Life After LASIK Web network, Kantis said in his transmittal that all of the ads violated Ulatowski’s 5/22 letter to LASIK professionals that set out requirements for LASIK promotions. FDA Webview reviewed four of the ads and determined that none of them complied with the letter, which among other things said such ads should disclose risks associated with the controversial procedure.

Kantis and other activists have been conducting a sustained pressure campaign on FDA’s new leadership to take regulatory action against ambulatory surgical facilities that they say perform LASIK vision-enhancement procedures without required patient informed consent and fair disclosure of permanent injuries that reportedly run as high as 20% of all surgeries. Since their complaints were aired at an open advisory panel meeting last year, CDRH has declined to respond to requests that it initiate inspections of these facilities to ascertain their compliance with MDR reporting requirements.

Last week, former CDRH chief of LASIK reviews Morris Waxler told FDA Webview the agency had “screwed up” in the adverse events it allowed LASIK lasers to cause when it approved this indication in 1998.

In a comment on Kantis’ complaint about the 18 ads, FDA’s Press Office told FDA Webview: “We acknowledge receipt of these ads and will give them appropriate review. Without enough time to review, it is not helpful to speculate on potential regulatory action, nor can we comment on an investigation should we initiate one.”

Meanwhile, FDA’s closure of a public docket it opened last year on LASIK quality-of-life issues occurs 9/14.

Former FDA Official Says FDA “Screwed Up” In Approving LASIK

Former branch chief for diagnostic and surgical devices alleges the FDA caved under pressure from ophthalmologists to approve LASIK devices, despite high incidence of complications.
Reprinted with permission from
On LASIK ‘We Screwed Up’ Says Ex-CDRH Review Leader

When it first approved laser devices for LASIK indications in 1998, CDRH “screwed up” in not establishing a standard for acceptable adverse events reported from clinical studies, former branch chief for diagnostic and surgical devices Morris Waxler told FDA Webview in a teleconference interview 9/3. Instead, FDA set upper limits in each product’s labeling and reference a voluntary guidance issued two years earlier. Joined in the interview by Life After LASIK founder Dean Andrew Kantis, who is conducting a post-operative on-line study of the procedure’s injuries, Waxler said FDA was under enormous industry pressure when it approved the new indication and its standards for the procedure “were cobbled together.”

Primarily, he said, CDRH totally lacked in-house LASIK expertise at the time and incorrectly judged the significance of adverse events, which input from an advisory panel had said should be less than 1% of all procedures. Actual experience was above 5% in permanent adverse events that the agency listed in the wrong column as so-called “second-tier complications” such as patient-reported persistent pain, blurred images and night-vision difficulties that were not counted as first-tier adverse events (retinal detachment, lost visual acuity, induction of astigmatism, etc.).

CDRH has been under mounting pressure as FDA’s most “dysfunctional” Center, and last month its latest director, Daniel G. Schultz, was moved to resign over its worsening problems, most recently to do with allegations about allegedly improper 510(k) clearances and low employee morale.

“I think we screwed up,” Waxler said of the 1998 approvals. “Nobody’s going to admit that. Basically, I think people made some of those judgments incorrectly. We were getting advice from very renowned ophthalmologists — more renowned than anyone we had in the agency. We dropped the ball with regard to enhancements with in excess of 10% retreatment rates because there was a great deal of pressure from individual doctors who said they had the freedom as a physician to re-treat when they felt it was necessary for the sight of the patient. We waffled on that, we collapsed on that issue. In some of the clinical trials we were very tough on particular companies that came in with high re-treatment rates, and none of that got translated into a requirement for all the manufacturers. So I think we screwed up.

“It’s very difficult to get them to admit there’s been an error. I just think that’s not going to happen until there’s such a crisis that they’re forced to do so.”

CDRH continues to refuse to act against the procedure or to conduct inspections at ambulatory surgical facilities to force the issue on non-reporting of LASIK adverse events under MedWatch and MAUDE, Kantis said. “The agency says, ‘Oh, we have no complaints coming in!’ They won’t listen to us.” Eighteen months ago, he said, CDRH had only 246 LASIK adverse events reported, a number that has risen to over 1,500 after mass media publicity around an advisory committee hearing on the issue in April, 2008.

“The agency doesn’t want to have a fight with the ophthalmologists,” Waxler said. “Why not?” demanded Kantis. “They’d feel weak,” Waxler answered.

Until enough patients have been injured to get together and mount a big lawsuit, Waxler observed, “neither the independent ophthalmologists nor the agency is going to stand up and do anything.”

FDA’s response

In a statement issued 9/8 by FDA’s Press Office, the agency said CDRH’s Ophthalmic Devices Division “never had standards stating that adverse events should be less than 1% for all procedures. In its consideration of LASIK applications, CDRH followed the October 10, 1996 guidance entitled ‘Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers’.” This guidance contains a section on “Definitions of Major Safety Endpoints and Target Values,” which does say as its fifth point, “Adverse events to occur in less than 1.0% of the population.” However, the guidance lists these “definitions” under a caveat: “endpoints and values are only guidance.”

Less than definitively, FDA’s statement added: “Prior to publication of the guidance document, preliminary drafts were discussed extensively at two public meetings of the Ophthalmic Devices Advisory Panel (7/20/1995 and 4/1/1996). Information from these meetings and input from the Eye Care Technology Forum (ECTF) working group, manufacturers, health care professionals, and consumers, was incorporated into FDA’s final guidance. (Oct 10, 1996). After publication, proposed expansions of the guidance were discussed at two additional public meetings of the Ophthalmic Devices Panel (10/21/97 and 10/22/1998). These discussions resulted in a broad consensus regarding the definition and acceptable levels of occurrence of adverse events in IDE clinical trials for refractive surgery laser systems. These were utilized in the subsequent reviews of LASIK pre-market submissions.”

With regard to Waxler’s comment on retreatments, FDA said it “has not approved retreatment for any LASIK device. Furthermore, FDA’s labeling typically contains the following precaution: ‘It is unknown whether LASIK is safe and effective for retreatment with this laser for LASIK, because it is unknown whether LASIK is safe and effective for repeating the LASIK procedure on the same eye.’

“With regard to the adverse event numbers,” FDA’s statement continued, “preliminary search indicates that subsequent to the 4/25/08 Panel, we received reports of 537 events. However, only 97 of them had a date of the event subsequent to the panel meeting. Only 18 of these were received as voluntary reports.”

The FDA statement responded to Kantis’ comment that “The agency… won’t listen to us” by citing the April, 2008 public advisory panel of outside experts that it convened “to listen to patient experiences with LASIK and consider how to improve information for patients and physicians about LASIK. In response to the feedback from the public and LASIK experts, we have been working on several improvements in our communications with the public regarding LASIK-related safety issues. Our accomplishments to date are listed and frequently updated on our web page entitled ‘Latest on FDA’s LASIK Program’.”

ASCRS’ John Ciccone disavows offensive videos


The American Society of Cataract and Refractive Surgery (ASCRS) held its convention earlier this year in San Francisco.  At the convention LASIK surgeons performed skits making fun of damaged and suicidal LASIK patients. One skit poked fun at patients who complain of halos and glare after refractive surgery.  The skits were published on YouTube by Parag Majmudar.  One of the skits featured Parag Majmudar as “Dr. I. M. Suicidal” singing of “pushing the boundaries of ethics”.

Last week a damaged LASIK patient stumbled upon the ASCRS convention videos on YouTube and sent a link to several other damaged LASIK patients.  The link was forwarded to Jim Dickinson of  Mr. Dickinson sent an email to John Ciccone, ASCRS Director of Communications, asking for confirmation that the objectionable videos were indeed from the ASCRS convention.  Mr. Ciccone confirmed that the skits were performed at the ASCRS convention, disavowed the videos, and stated that the videos’ producer would be asked to remove them from YouTube.

Although ASCRS is sorry that the videos were exposed, their apology changes nothing in the minds of damaged LASIK patients who have been trying for years to expose the corrupt LASIK industry for what they truly are  — liars in white coats, performing an unnecessary, harmful surgery and laughing all the way to the bank.

Email to LASIK Surgeon, William Trattler MD from damaged patient

Posted on 07-18-2009

July 16, 2009

I wanted to let you know I have seen many of your recent performances at the 2009 ASCRS convention mocking Lasik patients, singing about “ethics going out the window”.  All quite humorous to your colleagues I’m sure.

I also wanted you to know that I am not stupid and I know that you took my medical records from my attorney and then sat on them for three months, running down the statute of limitations before deciding you were “too busy”.

I am planning on using many of your quotes in your quite eloquent email to me about there being “no way to stop bad Lasik surgeons” in to letters to Senator Olympia Snow, Senator Susan Collins, Margaret Hamburg of the FDA and President Barrack Obama.  Since there is no way to stop surgeons like mine or hold them accountable in any way then the only recourse is to ban Lasik. Never mind the very questionable safety and satisfaction “statistics” widely quoted by the refractive surgery community.

And if self proclaimed ethical surgeons like yourself can turn the misery I’ve dealt with for the last 3 years into satire, you deserve to be exposed for what you truly stand for.  Profit over ethics and patient welfare.

Oh, and since resigning my irreplaceable position at LL Bean, I’ve finally gotten the blepharitis under some control without antibiotics.

So, I just need to find a $70K a year job where I can work in a humidity controlled environment, with minimal computer and reading somewhere in the Pacific Northwest or the rainforest and where I only work full time during daylight savings so I don’t have to drive after dark. And try to keep a roof over my head.

But since I am not damaged “enough” to successfully sue William Holt for some restitution even though he clearly committed malpractice (no one disagrees on that point), my story will become very public.  It’s just as well as I would never agree to sign a confidentiality agreement.  I will do everything in my power to make sure he can’t hurt anymore patients.

Natalie Messier
Brunswick, Maine


Open Letter to Director Timothy Ulatowski

Open Letter to Director Timothy Ulatowski
Posted 7/13/2009

June 27, 2009

Timothy A. Ulatowski, Director
Office of Compliance
Food and Drug Administration
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20850

Dear Mr. Ulatowski,

The recent FDA warning to consumers regarding Zicam cold products emphasized the seriousness of loss of smell and its effect on quality of life. But for years, the FDA has ignored the pleadings of patients who needlessly suffered visual impairment by LASIK eye surgery devices.

You need only consult readily available information already in FDA databases – for example the FDA Maude database of LASIK-related adverse events to see that LASIK eye surgery is exposing the public to unreasonable risk. There are hundreds of patient reports of chronic, debilitating dry eyes and incapacitating visual impairment after LASIK. Yet the FDA continues to fail to act on these reports by allowing these devices to remain on the market.

Is it the FDA’s position that the sense of smell has a greater impact on quality of life than sight? Can the FDA say that vision is less important to public health and safety than a sense of smell?

The LASIK industry is actively engaged in cover-up of the problems associated with LASIK surgery. The LASIK industry diverts attention away from emerging problems of LASIK such as LASIK-induced dry eye disease and night vision problems by feeding the media statistics about LASIK ‘satisfaction rates’ and patients achieving 20/20 vision for short periods of time after surgery. The LASIK industry doesn’t like to talk about night vision impairment and intractable dry eyes which may be debilitating and permanent after LASIK. The LASIK industry doesn’t want to discuss how poor quality (distorted) 20/20 vision after LASIK can be a waking nightmare for patients with LASIK-induced irregular astigmatism. And only in the alternate universe of ‘The LASIK Industry Money Machine’ is severe dry eyes merely a “side effect” and not a serious health concern.

None of the information in this letter is news to the leaders in the Center for Devices and Radiological Health (CDRH) and the Division of Ophthalmic and ENT Devices. You know about the hundreds of MedWatch reports related to LASIK injuries. You know about petitions to withdraw the approval of LASIK. You know that data submitted in the applications for FDA-approval of LASIK devices confirms that roughly 20 percent of patients experience dry eyes and night vision disturbances persisting beyond the endpoint of the clinical trials. You know that the body of medical literature demonstrates high incidence of dry eyes and night vision disturbances after LASIK. You know about LASIK-related suicides.

If Zicam can lead to loss of smell, then I believe the FDA took the proper action by issuing a warning to consumers. However, it is incomprehensible that the FDA would warn consumers to stop using a cold product due to risk of smell loss, yet fail to take swift action to protect the public from devices demonstrated to cause permanent impairment to the eyes of 20 percent or more of patients who undergo the LASIK procedure.

I implore you to explain the FDA’s position on this matter.

LASIK Activist Tells GAO, IG About 20-fold Injury Excess

Reprinted with permission from

Despite CDRH guidance limiting allowable medical device “complications” to 1%, it has approved lasers used in LASIK vision-correction surgery that exceeded a 20% complication rate in the clinical studies that supported their marketing applications. This is the basis of a 6/11 request by LASIK victim Lauranell H. Burch, who is molecular genetics core facility director at the National Institute of Environmental Health Sciences, that the devices’ approvals be revoked. She made the request in identical letters to the Government Accountability Office (GAO) and the HHS Inspector General.

Part of an escalating campaign to have FDA upgrade the devices’ labeling and enforce medical device reporting (MDR) requirements against ambulatory surgical facilities performing LASIK, Burch’s letters told the overseers that FDA “has been grossly negligent and has placed patients’ interests secondary to interests of medical device manufacturers.”

The letters follow by one day an appeal for presidential intervention from another activist and injured patient, and come less than two weeks before a scheduled 6/22 congressional presentation by injured patients and planned demonstration outside FDA headquarters.

Burch said about 700,000 people a year undergo LASIK, “largely as a result of aggressive and often-misleading advertising.” She did not mention CDRH compliance director Timothy A. Ulatowski’s cautionary message last month to eye professionals on marketing claims. Her letter linked CDRH’s other roles in the controversy to allegations by dissident Center scientists and physicians last October of corrupt scientific reviews.

Appending a bibliography of 19 footnoted medical literature citations, said adverse effects of LASIK are permanent and include:

  • Reduced the biomechanical integrity of the cornea, which may lead to late onset corneal ectasia requiring corneal transplant.
  • Corneal flap incisions that never completely heal and may be accidentally dislodged indefinitely.
  • Life-long increased risk of corneal microorganisms.
  • Corneal nerves which are severed and burned during LASIK and never fully regenerate normal densities and patterns, resulting in dry eye disease that can be permanent.
  • LASIK-caused inaccurate intraocular lens power calculations for future cataract surgery.
  • Inaccurate intraocular pressure measurement that exposes patients to risk of undiagnosed glaucoma and associated vision loss.
  • Persistent and accelerated keratocyte (corneal cell) death. This means that corneas that have undergone LASIK may not last the patient’s lifetime.
  • A reduction in quality of vision.

Burch called FDA’s 4/25/08 advisory committee meeting on injured patients’ complaints a “white-wash,” citing panel chairman and LASIK surgeon Jayne Weiss’ conclusion that “It appears to me from hearing what has been said today that this has really been a referendum on the performance of LASIK by some surgeons who should be doing a better job”. In the 14 months since then, Burch wrote, CDRH “has failed to respond to issues raised and requests for a moratorium on LASIK devices.”

Burch contended that LASIK-impaired vision, notwithstanding reported surveys showing high levels of patient satisfaction, are the cause of dangerous driving by people who have LASIK-induced loss of contrast sensitivity. “LASIK is a medically unnecessary surgery that carries with it substantial risk of permanent visual impairment,” she wrote. “As evidenced, LASIK complications occur frequently. With millions of LASIK procedures performed and high complication rates, it follows that LASIK eye surgery has become a leading cause of preventable visual impairment in the United States.

“I have submitted a Citizen’s Petition to the FDA to withdraw FDA approval of lasers for LASIK and have not received a response within 180 days as required by law. My petition is found at this link:  Failure of the CDRH to ensure rigorous clinical trials and to respond to serious post-market safety and effectiveness concerns regarding LASIK in adherence to established regulatory requirements have resulted in irreparable harm to millions of Americans and is indeed a ‘silent danger’ to public health. For the reasons outlined here, I request an immediate withdrawal of FDA approval of LASIK devices.”

LASIK Patient Advocate Writes Obama Seeking Intervention

Reprinted with permission from FDAWeb Review (

LASIK Patient Advocacy Network founder Scott A. Tolchin has written President Obama asking for intervention to help order a moratorium on LASIK eye surgery procedures due to an alleged increased rate of adverse events related to the procedure. Tolchin’s letter notes that patient advocates are planning a briefing on Capitol Hill 6/22 to discuss the moratorium request.

The letter acknowledges FDA’s recent interest in LASIK injuries, but it says the “problem is that the FDA alone does not have all of the necessary power to enforce the various aspects of LASIK issues that now threaten the public health and the strength of our economy, as more and more LASIK patients hit the disability roles. Advertising practices are governed by the FTC, doctor malpractice which is rampant is not being handled in a manner that proactively prevents adverse events from occurring, and when they do occur, LASIK patients encounter a ‘White Wall of Silence’ that prevents them from getting any justice, and has led to unprecedented incidences of depression, PTSD, and suicide.”

Additionally, the letter charges that FDA has operated in a corrupt fashion under the previous Bush administration by allowing laser devices to be approved that did not meet FDA guidelines or were cleared under a 510(k) based on a substantially equivalent device that was later recalled.

Here is the full text of Tolchin’s letter:

Dear President Obama,

I am writing to inform you of several issues regarding LASIK eye surgery that need to be addressed at a higher level than the FDA. On Monday, June 22, 2009 a group of LASIK patient advocates will be meeting on Capitol Hill to hold a congressional briefing on LASIK. At that briefing we will be calling for an immediate moratorium on LASIK eye surgery due to the fact that the adverse events are in the 30% range and are only allowed to be 1% or less according to FDA guidelines. This was all put into motion when I sent out 200 letters to congress, and filed a Citizen Petition with the FDA
(Docket # FDA-2009–P-0253-001/CP.)

Acting Commissioner of Food and Drugs, Joshua M. Sharfstein has opened an investigation into LASIK, and I believe that Commissioner Margaret Hamburg will be following up on this matter. The problem is that the FDA alone does not have all of the necessary power to enforce the various aspects of LASIK issues that now threaten the public health and the strength of our economy, as more and more LASIK patients hit the disability rolls. Advertising practices are governed by the FTC, doctor malpractice which is rampant is not being handled in a manner that proactively prevents adverse events from occurring, and when they do occur, LASIK patients encounter a “White Wall of Silence” that prevents them from getting any justice, and has led to unprecedented incidences of depression, PTSD, and suicide. I have documentation to support all of these assertions, most of which are listed in my petition on file with the FDA.

The FDA of the prior administration was rampant with corruption. There have been many instances of laser devices being approved that did not meet FDA guidelines or were approved on a 510(k) clearance based on a prior approved device that was later recalled by the FDA and the 510(k) devices are still on the market posing a dangerous threat to the public.

My group, LASIK Patient Advocacy Network is just one many LASIK patient advocacy groups participating in the briefing. The briefing is being sponsored by the National Research Center for Women and Families, and is being held in room HC-6, which was kindly secured with the assistance of Speaker Nancy Pelosi. I hope that you will send a representative from your office to the meeting and will assist us in bringing this matter to the public’s attention, and ensuring that the right steps are taken to protect the public health.

Mr. President, even if a LASIK patient has a perfect outcome from a LASIK procedure, there are several serious effects that they may not be aware of that could result in at best the need for glasses and contacts later in life and at worst the need for corneal transplants, corneal failure, loss of the LASIK flap, cataracts, and blindness. 100% of LASIK patients now have an open wound that was originally believed to heal. The LASIK flap never fully heals and makes the patient susceptible to increased risk of eye infections and diseases, inaccurate intraocular pressure measurements necessary for the detection of Glaucoma, and increased risk of the need for a corneal transplant should the patient lose the corneal flap by a poke or strike to the eye. Again, this is the situation for 100% of LASIK patients.

This procedure is an elective and unnecessary procedure whose risks far outweigh its short term benefits that only 70% of the patients may receive. I urge you to please consider supporting our call for an immediate moratorium on LASIK to protect the public while the FDA works through its investigation, which will surely show incidents of corruption with regard to laser manufacturers, conflicts of interest in LASIK studies that resulted in faulty data serving as the basis for FDA decisions, and a procedure that needs to be made illegal in the United States.

Thank you sincerely for your time to review and consider my request.

God Bless you. You are doing a wonderful job for the country.

Scott A. Tolchin
Founder, LASIK Patient Advocacy Network

LASIK Victims Ramp Up Protests at FDA, Capitol Hill

Reprinted with permission from

In a battery of new letters to FDA and its Capitol Hill overseers, protesters who say they have been permanently damaged by LASIK vision-correction surgery escalated their campaign this week to have the agency upgrade patient disclosures and warnings in the labeling of devices used and initiate inspections at ambulatory surgical facilities that, they allege, routinely fail to report adverse events to the agency. They say the letter campaign is to be followed by visits to key lawmakers this month and demonstrations outside FDA headquarters.

Following on a 5/26 petition to the agency seeking a medical device reports (MDR) enforcement effort by the agency, the letters complain that CDRH director Daniel G. Schultz has failed to follow through on promises he made in a letter 11 months ago to injured LASIK patient Michael Patterson, of Atlanta, GA. Other than a recent letter from CDRH compliance director Tim Ulatowski cautioning LASIK professionals about promotional claims, Schultz has made no substantive changes and “the inhumane breaches of the FDA regulations continue,” Patterson complains in a 6/1 letter to Schultz. A laid-off Northrop Grumman systems analyst and IT specialist, Patterson copied the letter widely to Capitol Hill overseers and to new FDA commissioner Margaret Hamburg.

The letter, and others like it from other eye-damaged patients in his network, complains about FDA continuing to “endorse (and fund) a plan to conduct a prospective quality of life after LASIK study in collaboration with biased LASIK surgeons who have clear financial conflicts of interest and who are under pressure from members of their professional societies to improve their LASIK profits.” Patterson’s letter contends that a “group of LASIK victims (PhDs, MDs, etc.) has offered to conduct a study for $50,000 to $100,000 total via a nonprofit organization and only asks the government to help obtain access to the patients (as required for any study).”

Patterson also alleges that LASIK surgeons regularly reuse 510(k)’d microkeratome blades for cutting pre-LASIK corneal flaps, contrary to CDRH public declarations that the devices are approved for single-use only. He and other LASIK victims say the industry has been concealing the fact that the corneal flaps never completely heal, permanently weaken the eye, expose LASIK patients to a lifetime of infection and blindness risks, and that intending LASIK patients are routinely deprived of adequate informed-consent documents, including an FDA-mandated Patient Information Booklet.

In a 6/2 letter to Schultz, Fort Lauderdale, FL-based microjet aircraft broker Dean Kantis, another network member, took the CDRH director to task for not pursuing under-reporting ambulatory surgical facilities. In his 7/22/08 letter to Patterson, Kantis wrote, Schultz had agreed with the concern about under-reporting “and stated that you were considering ways to address this important issue. You stated that FDA ‘has inspected three LASIK user facilities’ since 2000. Why were not more facilities inspected? What is the current number of LASIK user facilities that have been inspected? Are any inspections scheduled?

“We believe the FDA has failed to address the important public health concern of under-reporting of LASIK adverse events,” Kantis added.

In two separate statements on this report 6/3, FDA press officer Mary Long told us that the agency’s “plans for examining issues related to Lasik include an inspections component. While we can’t provide specifics on our investigations before they happen, I can tell you that they include inspections of hospitals and user facilities for adverse event reporting.” An earlier comment that sidestepped the protesters’ conflicted quality-of-life study, microkeratome blade reuse and patient disclosure allegations said:

“The FDA’s Web site documents potential risks to patients from LASIK. There are links to approved lasers, which lead also to the brochures that should be provided to patients.

“The FDA has an integral role in the design and execution of the study to evaluate prospective quality of life after LASIK. This study will be done in accordance with the rules governing FDA and NEI clinical trials. The FDA will objectively evaluate the information collected, and the outcomes of the study will be made public. The results of this study could lead to modification of FDA’s LASIK Web site, revised patient and physician labeling, and educational outreach.

“We are currently collaborating with the National Eye Institute (NEI) on a pilot study to validate the Web-based administration of previously validated paper versions of ophthalmic health-related questionnaires. Web-based administration of such questionnaires will help facilitate the pivotal study of patient-reported outcomes after LASIK. The pilot study is the first of its kind in the area of ophthalmology.

“Subjects with ocular surface disease and subjects with a normal ocular surface are being enrolled. People interested in participating in the pilot study at the NEI of the National Institutes of Health (NIH) in Bethesda, MD, and getting a free screening for dry eye and other ocular surface diseases, can learn more about the study by going to”

Citizen Petition to Inspect LASIK Clinics Filed With FDA

Posted 5/26/2009
Petitioner calls for inspection of LASIK clinics, sanctions for clinics that fail to report complications.

May 25, 2009
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dr. Margaret A. Hamburg
Commissioner of U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dr. Joshua M. Sharfstein
Principal Deputy Commissioner
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Daniel Schultz, M.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993


The undersigned submits this petition under section 519 of the Federal Food Drug & Cosmetic Act (21 USC 360i), or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs to request the Commissioner enforce compliance with medical device reporting (MDR) regulations by LASIK device user facilities and ASFs – Ambulatory Surgical Facilities (hereinafter referred to as “LASIK clinics”).


The petitioner requests the Commissioner of Food and Drugs inspect LASIK clinics to ensure compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements. Part 803 requires medical device user facilities to (1) establish written MDR procedures, (2) report adverse events to the manufacturer or to the FDA, and (3) submit annual reports to the FDA.

Further, the petitioner requests the Commissioner of Food and Drugs impose sanctions on non-compliant LASIK clinics as authorized under 21 USC 331 – 337. The regulation authorizes sanctions ranging from warning letters to injunction proceedings, civil penalties, and criminal penalties.


In 1998, the FDA approved the first excimer laser for LASIK. Since then, approximately 8 million United States citizens have undergone the surgery.

It is now well-documented that problems after LASIK, such as night vision difficulties and dry eyes, occur frequently after LASIK.1 A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved for LASIK from 1998 through 2004 found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes which are worse than before surgery, much worse than before surgery, moderately severe or severe.2

Other complications of LASIK, such as irregular-thickness flaps, partial or incomplete flaps, buttonholed flaps, free caps (the flap is cut completely off), flap striae (wrinkles), decentered flaps, flap dislocation, infection, inflammation, haze, epithelial ingrowth, vitreoretinal complications, optic neuropathy, induced cataract, and corneal ectasia occur infrequently but may lead to irreversible vision loss. Complications may emerge weeks, months, or years after seemingly successful LASIK, which contributes to underreporting.

Long-term consequences of LASIK include problems with future cataract surgery, risk of undiagnosed glaucoma due to inaccurate intraocular pressure measurements, permanent biomechanical weakening of the cornea with associated risk of late-onset keratectasia (corneal failure), life-long increased risk of corneal infection due to a permanent portal in the corneal periphery for microorganisms to penetrate, persistent loss of keratocytes (corneal cells), reduced corneal nerve density, reduced visual quality, and non-healing of the LASIK flap (exhibit 1) with associated risk of late flap dislocation. These issues affect virtually 100% of LASIK patients.

The FDA requires that all prospective LASIK patients receive the Patient Information Booklet (device labeling) from their surgeon prior to surgery. Device labeling is intended to inform patients of contraindications and risks. LASIK surgeons commonly fail to provide the device labeling to patients, which denies patients access to information that could affect their decision to have the surgery.

Microkeratome blades which are used to cut the LASIK flap are cleared by the FDA for single-use, although surgeons routinely reuse the blade on the 2nd eye of the same patient. Reuse of blades on multiple patients has also been reported, which may expose patients to infectious contaminants. It is reported in the medical literature that quality of the flap-cut is reduced with reuse of blades. This exposes patients to an increased risk of complications in the second eye. Furthermore, tissue remnants left on the blade from the first eye may be dragged into the interface of the second eye, leaving debris trapped in the interface.

Over the past several years, patients who suffered serious complications, visual impairment, or chronic dry eyes after LASIK petitioned the FDA to ban LASIK or otherwise restrict the devices to provide greater protection to the public from improper use of LASIK devices. The most recent petition (located at, Docket ID FDA-2008-P-0319) was received by the FDA in May, 2008. No response has been issued as required by law, and no action has been taken by the FDA to provide better protection for the public.

In 2007, reports of LASIK-related suicides began circulating in the mass media.3 In February 2008, preliminary findings of an Emory Eye Center study of suicides among organ donors were reported in the media. These findings suggested a four-fold increased suicide rate among cornea donors who had had LASIK compared to cornea donors who had not had LASIK.4 These media reports were vigorously disputed by LASIK surgeons and LASIK industry consultants who openly denied any connection between a bad outcome from LASIK and diminished quality of life, depression, and suicide.5

On April 7, 2008, the American Society of Cataract and Refractive Surgery (ASCRS), a LASIK professional group, issued a press release6 announcing collaboration with the Agency to study post-LASIK quality of life and stated that only “140 comments relating to LASIK dissatisfaction” had been reported to the FDA in the past decade. This number, in contrast to the reported incidence of complications in FDA clinical trials, is a clear indication that LASIK clinics are not reporting LASIK adverse events as required by law. ASCRS speaks on behalf of the FDA in the press release stating, “The FDA reaffirms that LASIK is both safe and effective.” Injured LASIK patients would like to know the name of the FDA source for that statement. Earlier statements by Dr. Daniel Schultz, Director of the Center for Devices and Radiological Health (CDRH) reported in Reuters7 on March 17, 2008, seem to contradict ASCRS.

In March 2008, the FDA announced a special hearing of the Ophthalmic Devices Panel to be held on April 25, 2008 to address patient experiences with LASIK. Injured LASIK patients who spoke during the open public hearing had harsh criticism of the FDA’s unprecedented partnership with LASIK professional groups to study LASIK dissatisfaction.8 Injured LASIK patients believe that LASIK surgeons are biased and lack objectivity, and that the proposed study amounts to the FDA putting the fox in charge of guarding the hen house.

At the hearing, injured LASIK patients and family members of LASIK patients testified to the devastating psychological impact of post-LASIK dry eyes and night vision disturbances, including depression, suicidal thoughts, and actual suicides.9 Several speakers called for a moratorium on LASIK.10

An FDA Patient Representative brought several serious concerns surrounding LASIK to the attention of the FDA at the April 25, 2008 advisory panel meeting. Her testimony is published on the FDA website at beginning on page 315.

As media reports of the FDA hearing circulated, self-reporting of LASIK adverse events by patients to the FDA surged to over 500 in one year. Undoubtedly, patients were previously unaware of the FDA’s voluntary MedWatch program for reporting problems after LASIK. A disturbing trend can be seen in the patient reports – poor night vision, halos, starbursts, debilitating dry eyes, diminished quality of life, and denial by the LASIK surgeon.

In September 2008, the FDA updated its LASIK webpage to clearly define halos, glare, night vision problems and dry eye as adverse events which should be reported to the FDA.

In April 2009, LASIK surgeons led by Kerry Solomon, M.D. published results of a “world literature review” on LASIK satisfaction,11 which combined data from 19 peer-reviewed studies of 2,199 patients. The articles report that 95.4% of LASIK patients are satisfied with their surgical outcome. The authors state, “Although this database also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life”. Incidence of night vision disturbances and dry eyes reported by patients in the 19 studies was known by Solomon’s group, but not published. Injured LASIK patients who believe the literature review was a deceptive marketing ploy located several of the 19 studies and found the incidence of dry eyes and night vision disturbances in the 20 – 30 percent range.

Injured LASIK patients allege that the LASIK industry has engaged in a cover-up of the frequency and life-altering nature of LASIK complications, such as night vision disturbances and chronic dry eyes, and have consistently ignored MDR reporting requirements. Based on the number of LASIK MedWatch reports which are self-reported by patients, there is compelling reason to believe that most LASIK device user facilities have never filed a single MedWatch report.

The petitioner has no knowledge of data or information which are unfavorable to the petition.


This petition qualifies for categorical exclusion under 21 CFR 25.30(a) from the requirement of an environmental impact assessment.


The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

Scott A. Tolchin
[Address, phone redacted]

1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jan;109(1):175-87.
2. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.
3. Puglionesi, L (2007, July 6). “Haverford man found dead at old hospital site.” Accessed 5/21/2009 from Delaware County Daily Times online at; “Suicide Series Part 1: Mid-Life Suicides” (2008, March). Accessed 5/22/2009 from WXOW ABC 19 online at; “Brentwood Officer Found Dead In Apparent Suicide”. (2008, March 17). Accessed 5/22/2009 from online at (LASIK blamed in suicide note presented at April 25, 2008 FDA panel meeting located at, slides 6 – 8)
4. Vollmer, S. (2008, February 3) Some link depression, failed LASIK. Retrieved 5/21/2009 from
5. Lindstrom, Richard. (2008, March 12) Letter to the News & Observer:; Morse M.D., Jennifer (2008, April 25) FDA Special Hearing on Post-LASIK Quality of Life:; Schallhorn, Steven C. (2008, February 3) Some link depression, failed LASIK:
6. “ASCRS to participate in and co-fund study on post-lasik quality of life with US Food and Drug Administration” (2008, April 7). Accessed 5/22/2009 at
7. Heavey, S. “FDA panel to review laser eye surgery” (2008, March 17). Reuters. Accessed 5/22/2009 at
8. See 4/25/2008 testimony of Matt Kotsovolos, Dr. Lauranell Burch, Dom Morgan, Dr. Michael Patterson, David Shell, and Dr. Michael Mullery on the FDA website at, and
9. See 4/25/2008 testimony of Beth Kotsovolos, Gerard Dorrian, Dr. Michael Mullery, Dr. Roger Davis, Dr. Edward Boshnick, and Todd Krouner on the FDA website at, and
10. See 4/25/2008 testimony of Dr. Michael Patterson, Matt Kotsovolos, Dr. Lauranell Burch, Dr. Michael Mullery, and Dr. Roger Davis on the FDA website at, and
11. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.
Exhibit 1

“Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force.” Source: October, 2008 publication of the American Academy of Ophthalmology (AAO), International Society of Refractive Surgery (ISRS), and Opthalmic Mutual Insurance Company (OMIC) titled “Is LASIK For Me? A Patient’s Guide to Refractive Surgery” located online at

“The corneal flap can be easily displaced following trauma many months after LASIK.” Source: Ramírez M, Quiroz-Mercado H, Hernandez-Quintela E, Naranjo-Tackman R. Traumatic flap dislocation 4 years after LASIK due to air bag injury. J Refract Surg. 2007 Sep;23(7):729-30.

“The LASIK flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed, with late traumatic flap displacement being reported as an infrequent complication.” Source: O’Brart DP, Mellington F, Jones S, Marshall J. Laser epithelial keratomileusis for the correction of hyperopia using a 7.0-mm optical zone with the Schwind ESIRIS laser. J Refract Surg. 2007 Apr;23(4):343-54.

“Our report, as well as the related literature, indicates that the healing of the flap is incomplete even 6 years after LASIK surgery.” Source: Landau D, Levy J, Solomon A, Lifshitz T, Orucov F, Strassman E, Frucht-Pery J. Traumatic corneal flap dislocation one to six years after LASIK in nine eyes with a favorable outcome. J Refract Surg. 2006 Nov;22(9):884-9.

“Although ocular trauma with corneal laceration can occur, we report that the lamellar flap is still susceptible to ocular trauma 7 years after LASIK. Informed consent should include discussion of long-term flap complications and patients should be advised to protect their eyes after LASIK, especially during high risk activities.” Source: Jin GJ, Merkley KH. Laceration and partial dislocation of LASIK flaps 7 and 4 years postoperatively with 20/20 visual acuity after repair. J Refract Surg. 2006 Nov;22(9):904-5.

“The fact that this potential plane can be disrupted many years after LASIK (7 years after the initial surgery in patient 1) indicates that corneal integrity is compromised by the surgical procedure and takes a long time, if ever, to restore.” Source: Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late Traumatic Flap Dislocations After LASIK. J Refract Surg Vol 22, May 2006

“Another aspect of LASIK surgery is that during this procedure, a corneal flap is made, which will create lifelong lamellar corneal potential space.” Source: Galal A, Artola A, Belda J, Rodriguez-Prats J, Claramonte P, Sánchez A, Ruiz-Moreno O, Merayo J, Alió J. Interface corneal edema secondary to steroid-induced elevation of intraocular pressure simulating diffuse lamellar keratitis. J Refract Surg. 2006 May;22(5):441-7.

“However, one aspect still in discussion is the wound-healing process in the created interface that leads to an easily removable flap even years after treatment.” Source: Priglinger SG, May CA, Alge CS, Wolf A, Neubauer AS, Haritoglou C, Kampik A, Welge-Lussen U. Immunohistochemical Findings After LASIK Confirm In Vitro LASIK Model. Cornea, Volume 25(3), April 2006, pp 331-335

“Corneal stromal LASIK wounds were found to heal weaker than normal because these structures were not regenerated during the healing response. Moreover, the central and paracentral stromal LASIK wounds were found to heal by producing a hypocellular primitive stromal scar that is very weak in tensile strength, averaging 2.4% of normal, and displays no evidence of remodeling over time in specimens out to 6.5 years after surgery.” Source: Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations.
J Refract Surg. 2005 Sep-Oct;21(5):433-45.

“However, this case illustrates that even 4 years following the procedure, the lamellar flap remains an inherently weakened area of the eye, susceptible to traumatic disruption.” Source: Nilforoushan MR, Speaker MG, Latkany R. Traumatic flap dislocation 4 years after laser in situ keratomileusis. J Cataract Refract Surg. 2005 Aug;31(8):1664-5.