Of the 700,000 people who undergo LASIK surgery each year, the vast majority are thrilled with their 20-20 (or better) results, with only 5% reporting dissatisfaction. However, a small fraction of patients-less than 1%-experience serious side effects like worse vision, severely dry eyes, night blindness, haloing, and constant pain.
Last week, an FDA advisory panel heard stories from frustrated members of this statistic, most of whom should have been told by their surgeons that they were not appropriate candidates for LASIK. (One in four who seek the surgery are not.) While the panel saw no reason to restrict the procedure itself, they urged the FDA to more strongly stress the already-existent warnings for potential patients.
The recommended emphasis would include the addition of illustrations showing what side-effect sufferers see, clarification of side-effect frequency, better explanation of what disqualifies a person for the procedure (such as large pupils), and elucidation of the virtual guarantee that nearsighted patients will eventually need reading glasses.
The FDA is planning a 2009 study to better understand who is having serious side effects and why.