FDA Wants to Mandate Warning of Potential Risks for Popular Eye Surgery

Nearly 25 years after approving LASIK eye surgery as a safe way to correct vision, the U.S. Food and Drug Administration (FDA) is saying that Americans should be better informed about the potential risks associated with the widely popular procedure.

LASIK stands for Laser-Assisted In Situ Keratomileusis. The procedure uses a cutting laser to permanently reshape the cornea—a dome-shaped clear tissue covering the front of the eye—allowing light to focus on the retina at the back of the eye without the help of eyeglasses or contact lenses.

In 1998, the FDA approved the first laser for LASIK surgery. Tens of millions of Americans have since undergone the procedure to fix their vision problems, although it can cost thousands of dollars and is rarely covered by health insurance plans.

In its latest draft policy proposal (pdf), however, the FDA said that people considering LASIK need to be better informed about the surgery’s potential side effects, including dry eyes, persistent eye pain, double vision, seeing glares or halos, imbalance between the two eyes, and other issues.

Specifically, the FDA recommends that LASIK manufacturers provide a copy of a detailed “patient decision checklist” to physicians and patients so that they have all the information needed to make an informed decision.

Besides potential side effects, the checklist would also include a list of health conditions that may put patients at greater risk if they choose to have LASIK, including controlled and uncontrolled diabetes, dry eyes, eye inflammation, or autoimmune tissue disease.

“It is important for people considering LASIK to have clear and understandable information on the benefits and risks of the surgery to help inform their decision on whether to get LASIK,” the FDA said on its website. “These recommendations, when finalized, are intended to help ensure physicians can share and patients can understand information about the benefits and risks of LASIK devices.

“Further, this information is intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that may uniquely pertain to individual patients,” the agency noted.

Concerns Over Warning

The draft was issued in July and the FDA received more than 600 public comments from Oct. 7 through Nov. 25. While some agreed with the agency that warnings are necessary, others argued that it focuses on the risks too much and could lead to patients being scared out of taking a procedure that’s generally considered safe.

Dr. Peter Hersh, a clinical professor of ophthalmology and director of the cornea and refractive surgery division at Rutgers New Jersey Medical School, said the procedure has been significantly improved over the past decades in terms of safety and outcomes.

“In fact, the visual result using equipment and algorithms today has steadily improved over the years with an excellent safety profile,” said Hersh, who was the author of the clinical trial that led to FDA’s approval of laser vision correction in the form of photorefractive keratectomy (PRK), a predecessor of LASIK.

“Of course, as with any other surgical procedure, there are risks and benefits, depending on an individual patient’s particular situation and examination,” the ophthalmologist added. “The risks and benefits of LASIK need to be discussed fully in the informed consent process. However, some of the statements in the guidance document are not entirely correct.”

“In 2022, LASIK remains an extremely effective and safe procedure in well-selected and informed patients,” Hersh said.