Former FDA official Morris Waxler, Ph.D., now President of Waxler Regulatory Consultancy LLC, has been making headlines with regard to LASIK vision correction. Dr. Waxler, who was in charge of approving LASIK devices between 1996 and 2000, retired from the FDA a decade ago. But in the past year, he has been contacted by patients upset and angry with their LASIK results because of issues with seeing halos, impaired night vision and excessive glare.
On September 22, Dr. Waxler met with FDA officials and requested that the agency issue a public health advisory to make sure patients know the risks of LASIK surgery.
Morris Waxler, Ph.D., now tells ABC News
he would not recommend LASIK to patients.
In an appearance on ABC News that day, Dr. Waxler said 50% of LASIK patients experience side effects and one-third continue to need glasses or contacts.
In a February 2010 appearance on ABC’s Good Morning America, Dr. Waxler had commented that the FDA was focused on eyesight improvement, rather than on subjective side effects. “I did the best I could … but in hindsight, it wasn’t good enough,” he said.
Dr. Waxler also shared his belief that the agency messed up in not requiring tougher standards for LASIK. The procedure, he said, causes “persistent vision problems with an overall success rate of less than 50% and a failure rate of more than 50%.”
Just days before he met with the FDA, the president of the American Society of Cataract and Refractive Surgery, R. Doyle Stulting, M.D., Ph.D., issued a letter to Dr. Waxler.
The letter said Dr. Waxler’s information was “filled with false statements, incorrect citations” and “mischaracterization of results from older lasers … and misrepresentations of the actual performance of modern excimer lasers for the correction of refractive errors.”
Nevertheless, at press time, Dr. Waxler was working on a citizens petition urging his former employer to stop “the epidemic of permanent vision problems” caused by LASIK.
The petition will implore the FDA to implement stricter controls over LASIK device manufacturers and practitioners who perform the surgery.