LASIK eye surgery has been around for more than 20 years, but a growing number of people have raised concerns about the procedure. Among them is Dr. Morris Waxler, a retired Food and Drug Administration advisor who voted to approve LASIK in the 1990s.
Last week, Waxler told CBS News that the procedure should be taken off the market.
“Essentially we ignored the data on vision distortions that persisted for years," Waxler told CBS This Morning in a segment that ran on Nov. 14. “I re-examined the documentation…and I said, 'Wow this is not good.’"
Laser-assisted in situ Keratomileusis, commonly known as LASIK, is a minimally-invasive surgery that uses a laser to reshape the cornea, the clear front surface of the eye, in order to improve vision. CBS News estimates that an estimated 20 million LASIK procedures have been performed since it was approved.
According to CBS News, Waxler petitioned the FDA in 2011 to voluntarily recall its approval of LASIK, which was denied. The FDA told CBS it “has not found any new safety concerns associated with LASIK devices.”
However, Waxler’s analysis of industry data suggests up to 30% of patients experience complications. A 2017 study published in JAMA Ophthalmology found that nearly half of patients who underwent LASIK experienced a new visual symptom post-surgery.
The FDA’s website reports some of these complications include dry eyes, blurred vision, visual symptoms such as glare or halos, double vision or trouble seeing at night and even a possible loss of vision. The New York Times found that other recent studies suggested LASIK patients “may also be at an increased risk for long-term eye complications.” The procedure also “can interfere with the detection of glaucoma” and lead to pain caused by nerve damage, The New York Times reported.
Waxler’s warning is not the first time that the alarm has been raised about LASIK. In 2008, patients who experienced adverse effects of the surgery and their families testified at an FDA meeting.
Eydelman M, Hilmantel G, Tarver ME, et al. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.JAMA Ophthalmol.2017;135(1):13–22.