[Federal Register: April 2, 2003 (Volume 68, Number 63)]
[Notices]
[Page 16055-16056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap03-82]
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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: consentagreement@ftc.gov, 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: consentagreement@ftc.gov. 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