August 16, 2011
Reprinted with permission from www.fdaweb.com
LASIK Patients Ask Hamburg’s Help on Deferred Petition 08/16/2011
While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to “carefully consider each signer’s remarks.”
Typical of such remarks were:
Eileen Newell, CA: “This issue is VERY important to me as I am one of the 20% of people with disastrous Lasik results. I have extremely dry eyes, starbursts, double vision, and severe depression. I can’t see my husband across from me at 12 feet or so. Can’t drive safely night or day. I am sick that I was misled regarding the chances of something like this happening.”
Vandana Gupta, India: “Because my life has changed forever. And because I have to start it afresh. And that is not easy.”
Robert Owen, United Kingdom: “Am now left with huge floaters constantly in my vision as a result of LASIK; a totally unnecessary practice.”
Janis Morrow, TX: “We came way too close to risk destroying our daughter’s eyes with this procedure. I pray they recall the lasik devices and outlaw the procedure.”
Zoltan Zeisky, PA: “I had LASIK, and I wish I could turn back the clock to undo my life altering MISTAKE!!”
Name not displayed, MO: “My brother has been practically blinded by LASIK surgery. He lives in chronic pain.”
Similar anecdotal testimony, although fewer in number, was given by injured LASIK patients at an April 25, 2008 meeting of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.
After hearing it all, panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute faulted the industry for its “aggressive marketing” but wimped out by suggesting it was something for the Federal Trade Commission to look into. Subsequent efforts to interest that agency in LASIK vendors’ promotional violations produced nothing.