![]() Paula Cofer, from Tampa, Florida, who testified in front of the FDA in 20, said her experience had started with visual symptoms. (The FDA notes that “a definitive causal link between Lasik and these reported psychological harms has not been established”.) If the FDA ends up issuing this draft guidance as final, it will provide a recommendation – not enforced – on how surgeons should inform patients of potential risks.Īccording to the draft, doctors would be advised to share with their clients that their corneal nerves “may never fully recover, resulting in dry eyes and/or chronic pain”, and that there have been reports of some patients who have experienced depression or suicidality they believe to be a result of the fallout from Lasik. Those comments include strongly worded rebuttals from ophthalmologists who say the procedure changes lives for the better, and regretful patients who wish they had never gone through with it. The guidance is not final a spokesperson for the FDA told the Guardian that the agency was currently in the process of considering hundreds of public comments submitted on the draft guidance. Those effects can show up as the presence of glare, halos, or starbursts, especially at night.Ī doctor performs laser eye surgery on a patient in Fairfax, Virginia. In one clinical trial from 2017, the FDA found that nearly half of participants reported experiencing “ new visual symptoms” after undergoing surgery. Last year, the FDA released draft guidance telling doctors that prospective patients should be warned they might be left with double vision, dry eyes, difficulty driving at night, and persistent eye pain. One investigation of an FDA database by the reporter Jace Larson found more than 700 complaints of severe pain, described as “worse than childbirth” or as if “their eyeballs would stick to their eyelids almost every night”. ![]() He says he regrets his role in bringing the procedure to the public.Īccording to his own analysis of industry data, the complication rate of Lasik falls between 10% and 30%. Dr Morris Waxler, a retired FDA adviser who voted to approve Lasik in the 1990s, is now one of its biggest critics. Doctors also say that using new lasers significantly decreases complications, compared with the older-generation models that were used in the early 2000s.īut patient advocates and some experts say that is not the full picture. ![]() The American Refractive Surgery Council says the procedure’s complication rate is less than 1% (though 30% of people may see short-term side effects like dry eyes). That extra step is not necessary to perform Lasik, but specialists who have it are more likely to get referrals from other generalists. Surgeons who perform Lasik must have the standard board certification in ophthalmology and it is recommended that a patient choose one with a one-year accredited fellowship in refractive and cornea surgery. Surgeons who perform Lasik view it as routine, touting surveys promising a customer satisfaction rate of 90% to 95%. Reeves is one of the 500,000 Americans who undergo Lasik every year to correct their vision ( about 100,000 people in the UK have the surgery annually). Robin Kyle Reeves and her husband, Michael.
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