A former Food and Drug Administration adviser who originally voted to approve LASIK eye surgery now says the procedure should be taken off the market.
“Essentially we ignored the data on vision distortions that persisted for years,” Morris Waxler, a retired FDA adviser, told CBS News. “I re-examined the documentation … and I said, ‘Wow this is not good.’”
Though an FDA patient survey found that more than 95 percent of patients were satisfied with their results following the surgery, which federal officials approved in 1998, others have suffered serious complications. Waxler told the outlet he estimates LASIK complication rates range between 10 and 30 percent.
LASIK surgery uses a special laser to reshape the cornea to improve the eye’s “focusing power,” according to the FDA.
On its website, the federal health agency details the risks associated with the procedure, which include loss of vision, “debilitating visual symptoms” — such as glare, halos and/or double vision — and severe dry eye syndrome. Additionally, there is no long-term data available on the procedure, meaning the “long-term safety and effectiveness of LASKI surgery is not known,” according to the FDA.
One LASIK patient told CBS News the surgery “ruined his life.”
“It’s a devastation that I can’t even explain,” said Abraham Rutner, an electrician from Brooklyn, N.Y. “Things would appear double. Around the lights were like having starbursts.”
Waxler, who in 2011 petitioned the FDA to issue a voluntary recall of LASIK but was denied, told CBS News the procedure should “absolutely” be banned.
“There’s nothing wrong with a person’s eyes who goes to get Lasik,” he said. “They have healthy eyes. They could go and get a pair of glasses.”
The FDA told CBS News in a statement that the agency “has not found any new safety concerns associated with LASIK devices.”
Fox Business’ Ann Schmidt contributed to this report.