LASIK Ads Misleading, FTC Charges

March 26, 2003

• FDA Panel Urges Clearer LASIK Warnings • FDA Approves New LASIK Device • Lasik Vision Center Settles False Advertising Charges • Banker Gets $7 Million in LASIK Suit • LASIK Ads Misleading, FTC Charges • Louisiana Eye Surgeon Fined $1 Million --- • More ...

The Federal Trade Commission (FTC) wants to clear up some of the advertising about LASIK eye surgery.

According to the Commission, the ads claimed that LASIK surgery - which is designed to improve the focusing power of the eye by changing the shape of the cornea - would eliminate the need for glasses or contacts for life, eliminate the need for reading glasses, and eliminate the need for bifocals.

Under the terms of the proposed orders with the Commission, both companies, The Laser Vision Institute, LLC and LCA Vision, Inc., doing business as LasikPlus (LCA), will be barred from making such claims in the future unless the claims can be substantiated.

"The Commission charged that these companies couldn't substantiate their claim that LASIK eye surgery would eliminate the need for glasses or contacts for life," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "Companies offering any medical procedure shouldn't need glasses to see this clearly: if you over-promise, the FTC will act."

According to the Commission's complaints, both LCA, based in Cincinnati, Ohio, and LVI, based in Lake Worth, Florida, violated Section 5 of the FTC Act by making unsubstantiated claims regarding the benefits, performance, and efficacy of the LASIK procedure. In addition, LVI allegedly made a false claim regarding "free" LASIK consultations, and LCA made an unsubstantiated safety claim about LASIK services.

The FTC's complaint against LCA alleges that the company failed to substantiate claims that its LASIK surgery services eliminate the need for glasses and contacts for life, and that the procedure poses significantly less risk to patients' eye health than wearing contacts or glasses. In addition, the complaint contends that LCA did not have substantiation for its claim that its procedure eliminates the risk of glare and haloing, a star-burst effect around lights at night, that can be caused by LASIK.

The Commission's complaint against LVI alleges that the company failed to substantiate claims that its LASIK surgery services eliminate the need for glasses and contacts for life, eliminate the need for reading glasses, and eliminate the need for bifocals. Further, according to the complaint, LVI falsely claimed that consumers would receive a free consultation to determine their candidacy for LASIK.

Instead, after an initial meeting with an LVI representative during which the representative quoted a price for the procedure based on their preferred treatment, LVI allegedly required consumers to pay a $300 deposit before they were told of the risks associated with the surgery, or if they were eligible candidates for the LASIK procedure. According to the FTC, the $300 deposit was nonrefundable if, after the initial consultation, the consumers elected not to have the surgery. The FTC alleges that only $200 of the deposit was returned to consumers who elected to undergo the surgery but subsequently were rejected for medical reasons.

To help consumers who are interested in LASIK eye surgery, the FTC has prepared a document entitled "Basic LASIK: Tips on LASIK Eye Surgery." It is available free from on the FTC's Web site.

Finally, when considering LASIK surgery, the FTC recommends that consumers keep the following in mind: First, like any surgery, LASIK has potential risks; talk to an eye doctor and then weigh the pros and cons of the procedure - consumers should not sign up with their "eyes wide shut."

Second, LASIK is not intended to correct presbyopia, or "aging eyes," the condition that requires most people to need reading glasses by their mid-forties. Third, LASIK surgery cannot be reversed; consumers may need additional surgery - called "enhancements" - to get the best possible vision after LASIK. Accordingly, consumers should consult their eye doctor about what to expect after the operation. Finally, most insurance plans do not cover the LASIK procedure.

The Commission's proposed consent orders are designed to prevent the two companies from engaging in similar acts or practices in the future when advertising their LASIK services.

Regarding LCA, the proposed order prohibits claims that LASIK surgery services or any other refractive surgery services: 1) eliminate the need for glasses and contacts for life; 2) pose significantly less risk to patients' eye health than wearing glasses or contacts; or 3) eliminate the risk of glare or haloing, unless the claims are substantiated by competent and reliable scientific evidence. "Refractive surgery services" are defined as any surgical procedure designed to improve the focusing power of the eye by permanently changing the shape of the cornea. Further, the proposed order requires that future claims about the benefits, performance, efficacy, or safety of any refractive surgery be substantiated by competent and reliable scientific evidence, and permits only device claims approved by the FDA under any new medical device application.

Regarding LVI, the proposed order prohibits claims that LASIK surgery services or any other refractive surgery services: 1) eliminate the need for glasses and contacts for life; 2) eliminate the need for reading glasses; or 3) eliminate the need for bifocals, unless the claims are substantiated by competent and reliable scientific evidence. The same definition of "refractive surgery services" applies, as do the other terms of the order related to claims about such services. The proposed order also prohibits LVI from misrepresenting: 1) that consumers will receive a free consultation that determines their candidacy for LASIK or any other refractive surgery services; 2) the cost to consumers to have their candidacy for such refractive surgery services determined; or 3) the information consumers will receive during a consultation for refractive surgery services.

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