Posts tagged with "Distorted cornea"

2020 hindsight: LASIK eye surgery should be taken off market, former FDA adviser says

November 15, 2019

Don’t turn a blind eye to the risks involved in LASIK eye surgery, an expert is warning, according to CBS News.

Laser vision correction has been popular for more than 20 years, with an estimated 20 million Americans undergoing the procedure to correct nearsightedness and improve distance vision.

According to an FDA patient survey, more than 95% of patients have been satisfied with their vision after surgery. But some patients say the surgery has ruined their eyesight. Among the complaints: “relentless eye pain,” dizziness, and detached retinas.

“Essentially we ignored the data on vision distortions that persisted for years,” said Morris Waxler— a retired FDA adviser who is now president of Waxler Regulatory Consulting. He voted to approve LASIK devices, but he now says voted to approve LASIK, but he now says that vote was a mistake.

“I re-examined the documentation … and I said, ‘Wow this is not good,'” Waxler told CBS News.

Waxler said his own analysis of industry data shows complication rates between 10%  and 30%. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. Three years later, the agency denied that request and now tells CBS News it “has not found any new safety concerns associated with LASIK devices.” 

Waxler said he thinks LASIK should “absolutely” be taken off the market. “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.”

Patient Abraham Rutner agrees, alleging that  LASIK surgery damaged his vision and nearly ruined his life. “It’s a devastation that I can’t even explain,” Rutner told CBS News medical contributor Dr. Tara Narula.

“Things would appear double. Around the lights were like having starbursts,” he added.

After months of not being able to drive or do his job, the Brooklyn electrician finally found help in Miami where optometrist Edward Boshnick fitted him with special contact lenses.

“His cornea is very distorted as a result of his LASIK surgery,” Boshnick told CBS.

Boshnick estimates he’s treated thousands of patients with LASIK complications.

Paula Cofer had surgery 19 years ago, “and from day one my vision was an absolute train wreck and it still is today,” she said.

She started a LASIK complications support group on Facebook and quickly found she was not alone. “You really have to understand you’re risking your only pair of eyes,” Cofer said.

Doctors who perform LASIK surgery said risks can be minimized with pre-surgical screening.

“The most important thing is knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur said.

Rutner now believes he was never a good candidate.

Here are FDA’s advisory on risks and how to find the right doctor for the procedure.

Research contact: @CBSNews