Ophthalmologists have been given 90 days to revise any advertising for <"https://www.yourlawyer.com/topics/overview/LASIK">LASIK eye surgery that makes false or misleading claims about the procedure’s safety and effectiveness. According to a Health Day News report, the ultimatum was made by the U.S. Food & Drug Administration (FDA) in a “Letter to Eye Care Professionals” issued last month.
“It’s about the false claims and not adequately providing consumers with information about the risks associated with the procedure,” an FDA spokesperson told Health Day News.
LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown
LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery. However, as Health Day points out, LASIK isn’t for everyone, and from time to time, patients may experience vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and or double vision.
On May 22, 2009, the FDA issued its first letter to eye care professionals regarding the promotion and advertising of LASIK surgery. That letter followed an April 2008, FDA Ophthalmic Devices Panel public meeting, at which the agency received information that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures.
In its latest letter dated September 23, the FDA said it continues to receive information concerning improper promotion and advertising practices by eye care professional.
“It is critical to disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the devices’ use. Advertisements and promotional materials that do not include appropriate risk information may be misleading,” the letter states.
“Any person, including an eye care professional, who misbrands a restricted device through false or misleading advertising, or by causing the device’s labeling to be false or misleading, violates the FD&C Act and is subject to enforcement action,” it continues.
Long Island ophthalmologist Dr. Eric D. Donnenfeld, who spoke on behalf of the American Society of Cataract and Refractive Surgery, told Health Day News the group supported the FDA’s action.
“A lot of patients make a decision based on an ad in a magazine or an audio clip on radio,” Donnenfeld said. He pointed out that “there are a lot of very good doctors who advertise, but it doesn’t mean a doctor is good because he advertises or offers group discounts.”
Donnenfeld told Health Day News that patients considering LASIK should choose a surgeon who is a member of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. LASIK surgeons should also be board-certified by the American Board of Ophthalmology, he said.
