[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16055-16056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7930]


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FEDERAL TRADE COMMISSION

[File No. 022 3098]


LCA-Vision, Inc. d/b/a LasikPlus; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices or unfair methods of competition. The attached Analysis to 
Aid Public Comment describes both the allegations in the draft 
complaint that accompanies the consent agreement and the terms of the 
consent order--embodied in the consent agreement--that would settle 
these allegations.

DATES: Comments must be received on or before April 25, 2003.

ADDRESSES: Comments filed in paper form should be directed to: FTC/
Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580. Comments filed in electronic form should be 
directed to: [email protected], as prescribed below.

FOR FURTHER INFORMATION CONTACT: Matthew Daynard, FTC, Bureau of 
Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC 
20580, (202) 326-3291.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  2.34 of 
the Commission's rules of practice, 16 CFR 2.34, notice is hereby given 
that the above-captioned consent agreement containing a consent order 
to cease and desist, having been filed with and accepted, subject to 
final approval, by the Commission, has been placed on the public record 
for a period of thirty (30) days. The following Analysis to Aid Public 
Comment describes the terms of the consent agreement, and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC Home Page 
(for March 26, 2003), on the World Wide Web, at ``http://www.ftc.gov/os/2003/03/index.htm.'' A paper copy can be obtained from the FTC 
Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. Comments filed in paper form should 
be directed to: FTC/Office of the Secretary, Room 159-H, 600 
Pennsylvania Avenue, NW., Washington, DC 20580. If a comment contains 
nonpublic information, it must be filed in paper form, and the first 
page of the document must be clearly labeled ``confidential.'' Comments 
that do not contain any nonpublic information may instead be filed in 
electronic form (in ASCII format, WordPerfect, or Microsoft Word) as 
part of or as an attachment to e-mail messages directed to the 
following e-mail box: [email protected]. Such comments will be 
considered by the Commission and will be available for inspection and 
copying at its principal office in accordance with Sec.  4.9(b)(6)(ii) 
of the Commission's rules of practice, 16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission has accepted, subject to final 
approval, an agreement containing a consent order from LCA-Vision, Inc. 
d/b/a LasikPlus (``LCA'').
    The proposed consent order has been placed on the public record for 
thirty (30) days for receipt of comments by interested persons. 
Comments received during this period will become part of the public 
record. After thirty (30) days, the Commission will again review the 
agreement and the comments received, and will decide whether it should 
withdraw from the agreement or make final the agreement's proposed 
order.
    This matter involves allegedly misleading representations about 
LASIK (laser assisted in situ keratomileusis) refractive surgery 
services designed to improve the focusing power of the eye by 
permanently changing the shape of the cornea (the clear covering of the 
front of the eye), thereby reducing patients' dependence on eyeglasses 
and contact lenses.
    According to the FTC complaint, LCA failed to have substantiation 
for the claims that its LASIK surgery services: (1) Eliminate the need 
for glasses and contacts for life; and (2) pose significantly less risk 
to patients' eye health than wearing glasses or contacts. Among other 
reasons, LASIK surgery does not eliminate most peoples' need for 
reading glasses, and the relative risks of LASIK surgery and wearing 
contact lenses over time are not readily comparable. The complaint 
further alleges that LCA did not have substantiation for its claim that 
its LASIK surgery services eliminate the risk of glare and haloing, a 
starburst effect around lights at night, that can be caused by the 
LASIK procedure.
    The proposed consent order contains provisions designed to prevent 
LCA

[[Page 16056]]

from engaging in similar acts and practices in the future.
    Part I of the 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 and 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.
    Part II of the order requires that future claims about the 
benefits, performance, efficacy, or safety of any refractive surgery 
service be substantiated by competent and reliable scientific evidence.
    Part III of the order permits device claims approved by the FDA 
under any new medical device application.
    Parts IV, V, VI, and VII of the order require LCA to keep copies of 
relevant advertisements and materials substantiating claims made in the 
advertisements, to provide copies of the order to certain of its 
personnel, to notify the Commission of changes in corporate structure, 
and to file compliance reports with the Commission. Part VIII provides 
that the order will terminate after twenty (20) years under certain 
circumstances.
    The purpose of this analysis is to facilitate public comment on the 
proposed order, and it is not intended to constitute an official 
interpretation of the agreement and proposed order or to modify in any 
way their terms.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 03-7930 Filed 4-1-03; 8:45 am]
BILLING CODE 6750-01-P