FDA Update on LASIK


Question: What has the FDA accomplished in the past year to protect the public from being harmed by LASIK? Answer: Not much.

March 27, 2009 (Gaithersburg, Maryland). Good morning. I’m Kwame Ulmer, Chief of the Diagnostic and Surgical Devices Branch, and this morning I’ll be giving an update on activities in our branch. On April 25, 2008, FDA convened a Public Advisory Panel of outside experts 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 public and LASIK experts, we’ve been working on several improvements in our communications with the public regarding LASIK-related safety issues.

Our accomplishments to date include FDA LASIK website. We’ve made it easier for LASIK patients to report problems within two clicks from the FDA LASIK website. On the FDA LASIK home page, select report a problem at the bottom left column, and then select report a LASIK problem to MedWatch. We’ve updated the other resources section of the website to provide a wider range of information about LASIK to patients and physicians. We’ve clarified the contact us section on how to submit a question about LASIK to FDA and how to submit a comment or concern about LASIK to the public record.

SightNet, we’ve updated related information in SightNet, a program used by healthcare professionals at participating facilities to share concerns about potential safety issues with ophthalmic medical devices and report problems to FDA. The updated information includes an emphasis that halos, glare, night vision problems, and dry eye from LASIK should be reported to FDA.

Patient information card, we’ve worked with the American Academy of Ophthalmology to develop a card that physicians can fill out with the patient’s eye measurements before LASIK surgery. Patients can keep this card to help the doctor calculate the lens implant power should they need to have future cataract surgery.

FDA recognition of ANSI laser systems for corneal reshaping. In March of 2009, FDA officially recognized the new LASIK standard from the American National Standards Institute, ANSI, entitled Laser Systems for Corneal Reshaping. FDA, as a member of ANSI, works closely with this and other national and international standards organizations. This group meets to develop and come to a consensus on appropriate national and international standards for device testing and performance.

LASIK docket. We’ve opened a public docket for LASIK so that any interested person can post questions, comments, or concerns regarding LASIK. This docket is web-based, and all comments submitted are able to be viewed by the public. All comments on the document are examined in excess by FDA staff on a regular basis. The LASIK docket can be found at www.regulations.gov and can be accessed with the keyword, LASIK, or typing in the LASIK docket number FDA-2008-N-0488.

These are just a few of the ways FDA is working to ensure that patients and physicians have current, accurate information to help them with their decisions about LASIK and to facilitate their reporting problems. As we continue to monitor the safety and effectiveness of LASIK, we’ll also explore additional ways that we can improve the quality of information available to the public about LASIK and ways to ensure that FDA receives better information about problems with LASIK. Thank you.


Source: Transcript of the 3/27/2009 FDA Ophthalmic Devices Panel. Available at: http://www.fda.gov/ohrms/dockets/ac/09/transcripts/2009-4423t1-001.pdf. Accessed April 30, 2009.

Lt. Col. Scott Barnes, M.D. Does ‘About Face’ on LASIK


In response to widespread reports of problems with LASIK eye surgery, the Food and Drug Administration (FDA) called a Special Hearing of the Ophthalmic Devices Panel on April 25, 2008 to address post-LASIK issues such as poor visual outcomes, debilitating post-LASIK dry eye, loss of quality of life, depression, suicidal thoughts, and a number of LASIK-related suicides.

Thirty-one presentations were given during the open public hearing, many from patients suffering from long-term complications of LASIK. Among the proponents of LASIK was Lt. Col. Scott Barnes, MD, an Army eye surgeon who made an impassioned plea on behalf of soldiers at Fort Bragg in North Carolina, “Please don’t take [LASIK] away from us.”

While Dr. Barnes spoke about “refractive surgery”, his testimony in the context of a special hearing on LASIK implied that his arguments were in support of the LASIK procedure.

Indeed, the Summary Minutes of the FDA hearing state that, “Dr. Barnes of the Warfighter Refractive Eye Surgery Program emphasized the importance of LASIK to the military.”

The FDA hearing testimony of Lt. Col. Scott Barnes is inconsistent with his recent publications. William Trattler, MD and Scott Barnes, MD published an article in the July, 2008 issue of Current Opinion in Ophthalmology,1 which states:

“At Fort Bragg, North Carolina, the Army surgeons have moved to 100% surface ablation in the past 2 years; the five known traumatic flap dislocations (out of 2500 procedures) due to ‘typical’ soldier activities contributed to this change but not as much as an analysis of the visual outcomes. A review of the 28,000 procedures has shown that soldiers with PRK or LASEK have a 20% greater chance of achieving an uncorrected visual acuity of 20/15 or better than soldiers with a similar level of refractive error undergoing LASIK.”

Since manuscripts typically require months in preparation and the editorial process before they appear in print, we can assume that Lt. Col. Scott Barnes was already aware of serious problems with LASIK eye surgery when he testified at the April 25th special hearing. Why, then, did Barnes fail to raise concerns about safety and efficacy of LASIK at the April 25th hearing? Did Army eye surgeon Scott Barnes intentionally mislead the FDA and the public during his testimony to the FDA?

Watch video of Lt. Col. Scott Barnes testifying before the FDA panel on April 25, 2008.


1. Trattler WB, Barnes SD. Current trends in advanced surface ablation. Curr Opin Ophthalmol.
2008 Jul;19(4):330-4.

Ophthalmologist Warns the FDA, LASIK is Russian Roulette


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”.

Source: FDA Maude Database Report

Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes?


Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that “Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.” Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?”

Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR…does not provide timely and usable data to staff or other system users…[and]…has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?

Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA’s intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

LASIK Industry Deceives the Public with Smoke and Mirrors


Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced ‘preliminary’ findings from an ‘unpublished’ review of medical studies showing a “95.4% global LASIK satisfaction rate”.

Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective.” When asked for clarification about the link between the study and the FDA, LASIK surgeon Kerry Solomon admitted that the study was performed independently from the FDA.

Clearly, this literature review was the LASIK industry’s attempt to reframe the discussion of last month’s FDA hearing concerning problems with LASIK. The review has not been published, but surgeons involved in the study report that 19 studies (2,199 patients) were selected from the thousands of LASIK studies in the body of peer-reviewed literature for the meta-analysis. This represents only .013% of patients who have had LASIK world-wide.

Interestingly, many more published medical studies show large percentages of patients experience complications after LASIK, even when the visual outcome is considered satisfactory.

Similarly, a published review of data for the twelve lasers approved by the FDA for LASIK between 1998 and 2004, including current technology, shows that six months after LASIK, 17.5 percent of patients report halos, 19.7 percent report glare (starbursts), 19.3 percent have night-driving problems and 21 percent complain of eye dryness. Based on these data, the lasers failed to meet the FDA’s safety requirements for approval.

Not only did the FDA approve unsafe devices for LASIK, the Agency also failed to enforce reporting of adverse events. When a patient experiences a bad outcome from LASIK, the physician should notify the manufacturer or the FDA by filing a MedWatch report. The medical literature contains hundreds of case reports of serious complications after LASIK, and thousands of medical studies of LASIK showing frequently occurring complications, yet the FDA recently announced that only 140 reports of adverse events after LASIK have been reported through MedWatch in the past decade. Apparently, most LASIK surgeons have never filed a single MedWatch report, even though all LASIK surgeons have patients with complications. And patients are not informed that they may voluntarily file their own MedWatch report. Clearly, adverse events from LASIK have been grossly underreported, and LASIK surgeons are not held accountable. In response to complaints from patient advocates, the FDA added a link to file a MedWatch report on its LASIK website in late May, 2008.

Patients feel FDA is disingenuous about interest in LASIK complications


LASIK is a 2.5 billion dollar per year industry.  LASIK is considered by some as the “gravy train” of ophthalmology.  Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.

In the past decade, several lasers have received FDA approval for use in LASIK surgery.  A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1  The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes.  It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.

The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK.  However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians.  The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts.  The panel was chaired by LASIK surgeon, Dr. Jane Weiss.  In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself.  Patients felt the hearing was a sham.

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study.  The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing.  The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK.  ASCRS fired back (see below) at the North Carolina newspaper that broke the story in February.  A flurry of bad press for the LASIK industry followed.  By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate.   Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment.  Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force.  One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression.  Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.

In a National Public Radio interview this week, , an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program.  Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?


“There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.”
Lindstrom, Richard. (2008, March 12) Letter to the News & Observer
Originally published at http://www.newsobserver.com/opinion/letters/story/996053.html


1. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.