Former FDA Advisor Says LASIK Should “Absolutely” Be Banned

Morris Waxler, currently retired from the FDA, voted in support of LASIK back when the FDA was first examining it. Now, decades later, he wants a LASIK ban.

LASIK eye surgery was approved by the U.S. Food and Drug Administration (FDA) more than 20 years ago, but now one former advisor for the agency is vehemently warning others against it. Morris Waxler, who is currently retired from the FDA, voted in support of the procedure back when the FDA was first examining it. Now, decades later, he wants it banned.

How LASIK Works

LASIK is a laser eye surgery that’s been used by millions of Americans to improve eyesight. It is performed by a doctor, who uses a laser or a thin metal blade to first separate the top layers of the cornea. Then a second laser reshapes the cornea in order to change its curvature to a point that eliminates the need for a corrective prescription. The whole procedure takes only about 20 minutes; however, there are complications associated with it—which is why Waxler believes it should no longer be performed.

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LASIK Side Effects vs. LASIK Complications 

Side effects like dry eye are common post-procedure, but more serious complications are also possible. Clinical data has found that up to 30% of patients experience side effects such as dry eye symptoms during the first three months post-surgery, while others may experience some pain, glare, halos, and night vision issues for 6 to 12 months. Thankfully, these side effects usually resolve during the patient’s healing process.

Complications, however, do not resolve over time and can be serious; they range from vision loss to chronic pain to detached retinas. “Essentially we ignored the data on vision distortions that persisted for years,” Waxler said of complications in an interview with CBS. “I reexamined the documentation … and I said, ‘Wow this is not good,'” Waxler explained, adding that the procedure should be “absolutely banned.”

According to Waxler’s own research on industry data, he believes that complication rates for the procedure are between 10% and 30%. The American Refractive Surgery Council, however, reports the complication rate to be less than 1%. 

Nevertheless, Waxler petitioned the FDA to issue a voluntary recall of LASIK in 2011. In 2014, the agency denied his request, stating that it has “not found any new safety concerns associated with LASIK devices.” 

While it’s important for patients considering LASIK eye surgery to understand the risks associated with the procedure, it’s also important to know that the surgery has successfully helped millions of people over the years. One study showed a patient-satisfaction rate of 95%, even going as far to say that “this surgery should be considered among the most successful elective procedures.” LASIK has an 81% Worth It Rating on RealSelf, with most of the negative reviews citing side effects like dry eye, night-vision issues and pain after the procedure. 

LASIK Alternatives 

For those still wary of LASIK, there are other treatments available for improving vision loss, beyond standard glasses and contact lenses. Implantable contact lenses, which are permanently implanted into the eye to correct nearsightedness, are a possible choice, although there are also risks associated with this surgery—most notably, scar-tissue buildup, cataracts, glaucoma, and chronic inflammation.
We’ve reached out to providers who specialize in LASIK for their insight on the latest debate surrounding the procedure and will update this article once we hear back.