Could LASIK Lead to 'Permanent Vision Problems'?

Sept. 22, 2010 -- A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA.

Morris Waxler, who is now an independent regulatory consultant, plans on filing a citizens petition urging the agency to take steps to stop what he calls "the epidemic of permanent vision problems" caused by LASIK.

Waxler's petition will implore the FDA to take actions to crack down on the procedure, including issuing a public health advisory that warns the public about the dangers associated with LASIK and implementing stricter controls over LASIK device manufacturers and practitioners who perform the surgery.

In the petition, Waxler will include data that he said were evidence that "LASIK causes persistent vision problems with an overall success rate of less than 50 percent; a failure rate of more than 50 percent."

Waxler said his change of heart came about after he retired from the FDA in 2000. He started getting complaints from people who suffered serious side effects from the procedure, including seeing halos, impaired night vision and excessive glare.

He was surprised when he looked back at the data presented when LASIK was undergoing the approval process in the late 1990s.

"When I looked back at that data, there was a tremendous consistency that show these problems exist in about 18 percent of people who had LASIK, most of them after I left the FDA," he said.

Some doctors, however, say while they agree with the estimate that thousands of people have had problems after having LASIK surgery, they stress that the vast majority of people are very happy after having the procedure done.

"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."