Devices

Former FDA LASIK Official Morris Waxler Dies at 88

Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the procedure, has passed away at the age of 88 in a hospital in Madison, WI. His wife, Carolyn Zahn-Waxler, said the cause was a stroke.

Waxler spent part of his career at FDA overseeing the evaluation of engineering and clinical standards for laser devices used in vision correction procedures. In 1998, under his leadership, the agency approved the first laser systems that enabled LASIK to become widely used in the U.S. as an alternative to glasses and contact lenses.

In subsequent years, however, Waxler reversed (see earlier story) his stance on the then-new procedure after reports and patient complaints about persistent complications began to accumulate. He concluded that some adverse outcomes were more serious and more common than initially understood and publicly called into question the safety profile of the surgery.

Adverse events related to LASIK and other laser eye surgeries have been a contentious issue for years. At issue in the long-simmering controversy is the level of adverse effects that should be tolerated — FDA accepts the industry claim of less than 2% while patient groups and other experts cite PMA data showing rates as high as 20%, pointing out that for a medically unnecessary, elective cosmetic procedure it should be close to 0%.

In 2019, Waxler told CBS News that approving the device was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler told the network. He said his own analysis of industry data shows complication rates between 10% and 30%.

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