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FDA Adviser Who Backed Lasik Now Opposes It

'We ignored the data on vision distortions,' expert says
By Bob Cronin,  Newser Staff
Posted Nov 14, 2019 7:15 PM CST
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(Newser) – Morris Waxler was so supportive of Lasik that he voted to approve the new eye surgery as an FDA adviser more than 20 years ago. He'd like to change his vote now. As horror stories mounted, CBS reports, "I re-examined the documentation … and I said, 'Wow this is not good,'" Waxler said. In the surgery, a laser is used to cut a flap to reshape the cornea at the front of the eye. Even the FDA's website has scores of accounts of complications posted by patients, including "relentless eye pain," dizziness and detached retinas. An optometrist in Miami said he's seen thousands of patients with Lasik complications. In two decades, 20 million people have had the surgery. A patient survey by the FDA found that more than 95% of patients were satisfied with their vision afterward.

But Waxler's own analysis found a complications rate of 10% to 30%. His petition to the FDA for a voluntary recall was rejected. "Essentially we ignored the data on vision distortions that persisted for years," he said. A woman who started a Facebook support group for patients with complications had the procedure 19 years ago, "and from day one my vision was an absolute train wreck and it still is today," she said. "You really have to understand you're risking your only pair of eyes." The FDA said it has no new safety concerns, per CBS. Doctors said outcomes can be improved by better screenings of patients. "There are people who really should not have this procedure," one said. (Patients who committed suicide after Lasik surgery include a Detroit TV station meteorologist.)

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