Unhappy LASIK patients urge FDA to take action

By Susan Heavey

GAITHERSBURG, Maryland (Reuters) - Patients unhappy with their laser eye surgery urged U.S. health regulators to do more to limit poor results, saying complications from the LASIK procedure have taken a toll on their sight and emotions.

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.