As Reported by the FTC:
For Release: March 26, 2003
Federal Trade Commission Stops Allegedly
Misleading Representations for Lasik Eye Surgery
Future Claims of Benefits,
Performance, Efficacy, and Safety Must Be
Substantiated
The Federal Trade Commission today
announced two complaints and proposed consent orders with two of the largest
purveyors of laser-assisted in situ keratomileusis (LASIK) refractive eye
surgery services, settling charges that their advertisements were not
substantiated by scientific evidence. 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, thereby reducing patients'
dependance on glasses and contact lenses - 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 its
principals, Marco Musa, Max Musa, and Marc'Andrea Musa (collectively, LVI)
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
cases mark the first actions the FTC has taken against the sellers of LASIK
surgery services for making allegedly false and unsubstantiated claims.
"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."
The Commission's Complaints
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,
as detailed below, 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.
Terms of the Proposed Orders
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.
Consumer Education
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 the Commission's Consumer Response
Center at the address provided below and can be found on the
FTC's Web site at:
www.ftc.gov/bcp/edu/pubs/consumer/health/hea04.shtm
The document provides the primary facts
related to LASIK surgery, including sections on what LASIK surgery is;
whether a consumer is a good candidate; how to find a surgeon; what risks
and complications may occur; what to expect before, during, and after
surgery; and what alternatives are available. It also contains the phone
numbers and addresses of a wide range of resources for information about
LASIK, including the American Academy of Ophthalmology, the National Eye
Institute, and the U.S. Food and Drug Administration.
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 vote to file each complaint
and settlement was 5-0. The Commission is
accepting public comments on the proposed settlements until April 25, after
which it will determine whether to make them final.
NOTE: The agreements referenced in this
release are for settlement purposes only and do not constitute an admission
of a law violation.
Copies of
the complaints, consent agreements, and analyses to aid public comment are
available from the FTC's Web site at http://www.ftc.gov and also from the
FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580. The FTC works for the consumer to prevent
fraudulent, deceptive, and unfair business practices in the marketplace and
to provide information to help consumers spot, stop, and avoid them. To file
a complaint, or to get free information on any of 150 consumer topics, call
toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at
http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft,
and other fraud-related complaints into Consumer Sentinel, a secure, online
database available to hundreds of civil and criminal law enforcement
agencies in the U.S. and abroad.
- MEDIA CONTACT:
- Mitchell J. Katz
- Office of Public Affairs
- 202-326-2161
-
- STAFF CONTACT:
- Matthew Daynard
- Bureau of Consumer Protection
- 202-326-3291
(FTC File Nos. 022-3098; 022-3053)
(http://www.ftc.gov/opa/2003/03/lasikads.htm)
Related Documents:
LCA-Vision, Inc d/b/a
LasikPlus, File Number 022-3098
The Laser Vision
Institute, LLC, File Number 022-3053
Basic LASIK:
Tips on LASIK Eye Surgery
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