Blurred vision, dry eyes, glare and double-vision have led  to depression and in some cases suicide, several patients told  a U.S. Food and Drug Administration advisory panel. “Since LASIK, I am visually handicapped,” said patient  David Shell, adding that he has near constant eye pain and  depression. “My eyes never feel comfortable... 10 years have  passed and I still suffer from this problem.”    Millions of Americans have had successfully undergone  LASIK, or laser-assisted in-situ keratomileusis, which uses a  laser to reshape the eye’s cornea, making them less dependent  on glasses or contact lenses. Surgeons and other industry representatives told the FDA’s  outside advisers most LASIK patients are satisfied with their  vision. They noted depression is a complex condition and that  no studies show a direct link to laser eye surgery. Still, the FDA is taking another look at the surgery after  receiving 140 reports of side effects and device malfunctions  between 1998 and 2006. The FDA wants its panelists’ advice on what information it  would add to its website or product labeling to help those  considering undergoing LASIK. “Most of the patients who are having these procedures are  fairly satisfied and are doing well. Clearly there is a group  who are not satisfied and do not get the kind of results they  expect,” Daniel Schultz, head of the FDA’s device center, told  reporters on Thursday ahead of the meeting. Several unhappy patients at the advisory meeting faulted  their surgeon for not ruling them out as a poor candidates for  LASIK, or for failing to stress the severity of possible side  effects. The FDA, which has said the surgery is safe and effective  regulates LASIK devices but not the surgeons or clinics that  offer the procedure. Stock analysts have said the FDA focus on the procedure  could further hurt LASIK companies, which have already seen the  softening U.S. economy dampen demand for the elective surgery  that is usually not covered by health insurance. LASIK device makers include Advanced Medical Optics Inc,  Alcon Inc and Bausch & Lomb, among others. TLC Vision Corp and  LCA-Vision Inc run LASIK clinics. Eric Donnenfeld, an ophthalmologist at New York University  Medical Center, said the surgery aims to improve patients’  lives. “The reality is that, following LASIK, the great majority  of our patients see as well or better than they ever saw with  their glasses or contact lenses with which they were unhappy,”  he told the advisory panel. Still, some patients said that while their vision had  improved, dry-eye and other side effects were overwhelming. The FDA is also planning to begin a study on LASIK patient  satisfaction in 2009 along with the National Eye Institute and  two industry groups: the American Society of Cataract and  Refractive Surgery and the American Academy of Ophthalmology. Patient and consumer advocates at Friday’s meeting objected  to the groups’ involvement with the study, citing conflicts of  interest. Industry representatives said it would help them  understand why some patients are unhappy with their LASIK  results. Advanced Medical Optics shares were off 1.1 percent to  $19.84 in noon trading, while Alcon shares were off 0.2 percent  to $154.68, both on the New York Stock Exchange. TLC Vision shares were down 2.5 percent at $1.19, while  shares of LCA-Vision were off 0.6 percent at $12.03, both on  Nasdaq.
Unhappy LASIK patients urge FDA to take action.