Latest Blog Articles

Violative Medical Device Ads: Why FDA Doesn't Act

FDA has statutory authority to regulate the advertising and promotion of "restricted" medical devices, but even in the face of injured patient complaints, it's an authority it rarely uses. That's probably because in the broad sweep of device safety issues and recalls that grab headlines and congressional attention, complaints about ads from injured patients directly to the agency's Center for Devices and Radiological Health are few and far between. And that's probably because injured patients don't know that CDRH is supposed to be regulating violative device ads.


Shuren Promises Action on Suicidal LASIK Patient

In her email, Cofer told Shuren she had found the patient's 5/22 report in CDRH's MAUDE database, in which the patient said: "I had Lasik 5 years back and it burns like 'profanity'. Feel I should commit suicide, got conjunctivitis and the conditions worsened. I'm fed up, using tears natural and a steroid. Please help."


Hundreds Petition Congress to Fire CDRH's Shuren

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office.


Despite Protests, FDA Hangs Tough on LASIK

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has "not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device."


1,073 LASIK Victims Ask FDA to Reconsider Petition Denial

Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought the market withdrawal of LASIK-indicated device and a public health advisory.



  • The producer of one national news program that did a special on Lasik told me that he's never seen anything like the way the Lasik industry has "circled the wagons" around incompetent docs, unethical Lasik mills, and deceptive advertising. Since they won't do the job of policing their own, it is left for people who have had bad experiences to do it for them.

    Joe Tye, author, speaker and CEO.
  • I am an optometrist, and I have seen many many patients who had bad LASIK outcomes. I cannot recommend this procedure to any patient after what I've seen in my exam chair. The rigid contact lenses required to correct corneas butchered by LASIK are complicated to fit, very expensive, and much less comfortable than most people's glasses or soft contact lenses. As a glasses-wearing myope myself, I would NEVER risk ruining my eyes with LASIK

    Dr. Amanda Zeller, OD
  • If a patient is willing to take a chance, my experience has been sometimes you win and sometimes you lose.

    Mark Packer, MD
  • I would not be willing to take even a 1 in 500,000 risk on my eyes.

    Dr. George Waring III
  • Ease of lifting the corneal flap 6 years after LASIK suggests that the interface remains a potential space, providing an easy conduit to the environment. We present the first reported case of Shewanella putrefaciens keratitis after LASIK and emphasize that flap-related complications can occur many years after the procedure.

    (Park et al, 2007)
  • Recently, the visual optical system has taken on a new clinical significance in refractive surgery, since current refractive procedures can and do induce large amounts of higher-order ocular aberration that often affects the patient’s daily visual function and quality of life.

    (Yang et al, 2010)
  • Furthermore, if [LASIK] interface transparency is indicative of absent wound healing, one might expect that the interface remains a potential space and flap adhesion is impaired for the lifetime of the flap.

    Ursea R, Feng MT
  • We seldom get to hear what patients want or value because in the real world disappointed patients rarely tell doctors to their face that they think of them.

    Dr. Shaili Jain
  • More than 90 percent of our knowledge is obtained through our eyes, making vision the most valued of the senses.

    Boston Foundation for Sight website.
  • Rarely do we encounter such a disturbing example of a trusted medical professional allegedly putting personal greed ahead of patients' health and safety.

    Indiana Attorney General Greg Zoeller on the indictment of cataract and LASIK surgeon, Dr. Philip Gabriele
  • It was once believed that the flap would re-adhere permanently. However, the unique connective tissue of the cornea and a lack of blood vessels limit its ability to fully heal even years after the procedure... A trauma to the face, such as impact from an automobile air bag provides enough force to dislodge the flap, reopening the cornea, infecting it with dirt and debris, and causing instant loss of visual acuity.

    Dr. Gary Conrad
  • Would I ever get LASIK?... Being an ophthalmologist with blurry vision would handicap me. Finally, I do have dry eyes, which could get worse. I'll stick to my glasses and contacts for now.

    Rachel K. Sobel: 3/30/2009
  • From what I have seen and witnessed in my many patients, I feel at the present time LASIK presents a significant public health crisis.

    Dr. Edward Boshnick
  • At 6 months postoperatively, the LASIK eyes experienced a 48% reduction in corneal biomechanics...

    Jorge Cazal, MD. OSN SuperSite 2/19/2008
  • These results show that although refractive results after LASIK are relatively good in the short term, they tend to decline over time

    Waldir Neira Zalentein, MD; Timo M.T. Tervo, MD and Juha M. Holopainen, MD. Seven-year Follow-up of LASIK for Myopia. J Refract Surg. 2009;25:312-318.
  • There was evidence presented by Emory University’s Henry Edelhauser at this year’s Refractive Surgery Subspecialty Day at the Academy of Ophthalmology meeting that the LASIK flap never actually heals onto the underlying stroma, especially centrally... This was a real eye-opener for me...

    Dr. John Kanellopoulos Review of Ophthalmology 2/1/2009
  • Make sure the first patient you enroll feels like you have been doing this for years...

    Stephen S. Lane, MD EyeWorld October, 2005


If you or someone you care about is thinking of undergoing LASIK/LASEK Laser Eye Surgery, then please take your time to read all the information provided on this site, and if you can, use the Links to other sites, so that you can make an informed decision.

If you have had a bad outcome then please speak out by reporting your complication. People are suffering, if you are willing to stand up to help them and prevent others from going through the same problems, or if you have had surgery and are unhappy to find out that the lasik flap can be easily dislodged for the rest of your life, or that the clinic used toxic MMC in your eyes, then please sign the petition! We need YOUR help!