– A former FDA official, Morris Waxler, who initially aided in approving the eye surgery correction LASIK procedure in the 90’s and later recanted is now taking the issue to the regulators at the Food and Drug Administration.
Waxler is now an independent regulatory consultant and plans to file a citizens petition, trying to get the FDA to stop the “epidemic of permanent vision problems” that are being caused by the LASIK eye surgery. He urges the agency to issue public health advisories warning on the problems associated with the eye surgery and enforcing stricter controls on laser eye clinics, specialist laser eye surgeons and LASIK device manufacturers.
Waxler has data that provides evidence that this eye surgery “causes persistent vision problems with an overall success rate of less than 50 percent; a failure rate of more than 50 percent.”
Some doctors say that though they agree with the estimate that thousands of patients have had issues after the surgery, they stress that the overwhelming majority of users are extremely happy after the LASIK procedure.
“Ninety-nine percent of people who have had LASIK have excellent results,” said Dr. Robert Cykiert, clinical associate professor of ophthalmology at NYU Langone Medical Center. “Millions of people have had the procedure done with a high success rate.”
Doctors emphasize LASIK surgery is no different from any other medical or surgical procedure, they also state that even if a patient seems to be ideal candidate for the intervention, the eye surgeon is very skilled and the equipment used is top-of-the-line, problems still occur, so there is no clear-cut way to know beforehand if a person will be troubled with LASIK side-effects
“It’s very hard to quantify these side effects, such as determining how to measure how bad things like glare and halos are,” Asbell stated. “It’s hard to pin down risk factors that differentiate the people who have problems from the ones that don’t so we can try to learn more.”
Cykiert also added that the scores of patients who have had LASIK issues are completely entitled to complain to the FDA, and that information they provide can be helpful for future candidates and doctors too.