• BREAKING NEWS ABC shows live and on-demand -- Download the WATCH ABC app!

Former FDA regulator questions Lasik safety

September 22, 2010 12:00:00 AM PDT
About 700,000 Americans get Lasik done to correct their vision problems. Now a former FDA regulator, who helped approve the procedure, says not only do many Lasik patients end up side effects the procedure may not be safe.No more contacts. No more glasses. That's why 29-year-old Hailey Bright underwent Lasik seven years ago and she's never looked back.

"I actually see better then 20/20. I see more like 20/15. It has been really amazing," said Bright.

A recent FDA survey found 95 percent of patients say they're satisfied with their results. But that's not what former FDA regulator Morris Waxler found. He helped approve the procedure in the 1990s. Now, he says 50 percent of the time, Lasik fails.

"It is right there in the record," said Waxler. "People know that these problems occur."

Waxler says up to 38 percent of Lasik patients continue to need glasses or contact lenses. Eighteen percent of Lasik-treated eyes have persistent dryness, glare and other night driving and vision problems. And one percent of patients have other adverse effects.

"The chance of having serious problems is very low," said ophthalmologist Dr. Jonathan Davidorf.

Dr. Davidorf has performed tens of thousands of Lasik procedures. He says the majority patients don't have side effects.

And if a Lasik patient still needs to use glasses occasionally or experiences a slight decline in vision over time, most like Michelle Vartanian say the benefits vastly outweigh the risks.

"You have to decide what the risk and complications are and what is more important to you," said Vartanian.

Dr. Davidorf says patients who are unsatisfied with their results usually had unrealistic expectations, were not good candidates to begin with or went to less experienced doctors.

He says do your homework.

"You need to get recommendations from people you trust. You've got to do your own research. Go in and have a consultation with two or three doctors before you actually make your decision."

Dr. Waxler wants government regulators to force Lasik manufacturers and surgeons to be more forthcoming about the potential side effects.

He also petitioned them to consider withdrawing the pre-market approval of Lasik equipment which could mean doctors would not be able use the devices. Waxler's meeting with the FDA was not a hearing and there is no word yet on if or when the FDA will respond.

Do you want the Eyewitness News team to call you? Get a FREE Morning Wake-up Call and personalized weather report at abc7.com/wakeup


Load Comments