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1
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EXHIBITS A - E
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EXTRACTED KEY WORDS
CORRECTION VISION LASER IRIOSRL THMR RAM RISKY GLASSES OVER2 MEDIA RISKS ELECTIVE SURGERY WIDESPREAD FRIEVISION SCHEDULE LENSES SIGHT WITH1 JIFETIME CODI LASIKPLUS LASER VISION NURSE SUCCESSFUL PROCEDURES WORLDWIDE FOREVER DISCOMFORT DOUG/KIM MONTAGE SEQUENCE DISSOLVE |
RESPOND2
LasikPLLus :120 spot
Fourth Draft v.1 & v-2
Draft Date: 11/12/01
MUSIC UP: "STRESSFUL" THEME
OPEN ON GRAPHIC PAGE: [SHOULD BE BREAKDOWN FROM CLIENT]
GLASSES OR CONTACTS WILL COST OVER $10,000 OVER 10
PERIOD. (DISCLAIMER: AVERAGE COST)
ANNOUNCER
(voice-over).
Did you know you could spend over
$10,000 on glasses and contacts over
the next 10 years?
DISSOLVE TO MONTAGE SEQUENCE OF DOUG/KIM PUTTING ON
GLASSES/TAKING OUT CONTACTS.
ANNOUNCER
(voice-over)
Not to mention all the time, hassle
discomfort.
MUSIC: CHANGE TO UPBEAT THEME
_..
-- -~- -D~S-SO-LV-~--TO---NEW--GRAPH~T~~-PA-~~~-WTTH---EYE~-AND--ROT~~ING
ELEMENT W/SUPER: BE FREE [FROM YOUR GLASSES and CONTACTS /
FOREVER]
ANNOUNCER
(.voice,over)
&&`nb& there's a way you could be .free
fiom your glasses or contacts forever'.
.
correction provider! Our plusses make
the difference.
GRAPHIC: GRAPHIC PAGE WITH "THE LASIKPLUS DIFFERENCE"
HEADER AND A ROW OF "PLUSSES" DOWN THE LEFT SIDE. A
SNIPPETS:
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2
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COMPLAINT
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EXTRACTED KEY WORDS
LASER VISION CORRECTION GLASSES FEDERAL TRADE COMMISSION FACTS LASIKPLUS TRADE COMMISSION ACT REPRESENTATIONS EXHIBIT LENSES RESPONDENT EYE SURGERY SERVICES RISKS CORNEA PARAGRAPH FLAP LIFE GLARE MYTH EXPENSE HASSLE SIGHT LIFETIME MEDIA ADVERTISEMENTS LASIK COMMERCE REFRACTIVE SURGERY SERVICES REASON |
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
)
)
In the Matter of )
)
LCA-VISION, INC. d/b/a LASIKPLUS, ) DOCKET
a corporation. )
__________________________________________)
COMPLAINT
The Federal Trade Commission, having reason to believe that LCA-Vision, Inc., a
("respondent"), has violated the provisions of the Federal Trade Commission Act, and it appearing to
the Commission that this proceeding is in the public interest, alleges:
1. Respondent LCA-Vision, Inc. ("LCA") is a Delaware corporation with its principal office
place of business at 7840 Montgomery Road, Cincinnati, Ohio 45236. LCA provides refractive
surgery services under the brand name LasikPlus.
2. The acts and practices of respondent alleged in this complaint have been in or affecting
commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act.
3. Respondent has advertised, offered for sale, and sold directly to the public refractive
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
and contact lenses. These surgery services include, among others, LASIK (laser assisted in situ
keratomileusis). In LASIK, a computer-assisted surgical knife, called a microkeratome, is used to
a flap in the cornea. A hinge is left at one end of the flap. The flap is folded back revealing
the middle section of the cornea. Pulses from a computer-controlled excimer laser then vaporize a
portion of the stroma and the flap is replaced. Excimer lasers and microkeratomes are "devices"
the meaning of Sections 12 and 15 of the Federal Trade Commission Act, and refractive surgery
services are "services" within the meaning of Section 12 of the Federal Trade Commission Act.
Page 1 of 4
4. Respondent has disseminated or has caused to be disseminated advertisements through various
broadcast, print, and outdoor display media, public seminars, and direct mail, including but not
necessarily limited to the attached Exhibits A - E. These advertisements contain the following
SNIPPETS:
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3
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ANALYSIS
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EXTRACTED KEY WORDS
LASIK SURGERY RISK GLASSES SUBSTANTIATION EYE LCA REFRACTIVE SURGERY SERVICES AGREEMENT COMMISSION CONSENT ORDER WEARING GLASSES PATIENTS PUBLIC RECORD RELIABLE SCIENTIFIC EVIDENCE COMPETENT HALOING GLARE EYE HEALTH LIFE COMPLAINT LENSES CORNEA PERMANENTLY CHANGING FOCUSING POWER ALLEGES ADVERTISEMENTS SAFETY EFFICACY PRACTICES |
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
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
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
LASIK procedure.
The proposed consent order contains provisions designed to prevent LCA 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
services: (1) eliminate the need for glasses and contacts for life; (2) pose significantly less
patients' eye health than wearing glasses or contacts; or (3) eliminate the risk of glare and
unless the claims are substantiated by competent and reliable scientific evidence. "Refractive
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,
safety of any refractive surgery service be substantiated by competent and reliable scientific
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
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)
under certain circumstances.
SNIPPETS:
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4
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AGREEMENT
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EXTRACTED KEY WORDS
COMPLAINT COMMISSION REPRESENTATION PROPOSED RESPONDENT FEDERAL TRADE COMMISSION AGREEMENT MANNER ACCEPTANCE SURGERY SERVICES DRAFT COMPLAINT SUCCESSORS TERMINATE SALE ADVERTISING RELIABLE SCIENTIFIC EVIDENCE VIOLATION REFRACTIVE SURGERY SERVICES OFFICERS PRACTICES ACTS APPEALING CONSUMER PROTECTION AFFECTING SUBSTANTIATES NOTIFY PURSUANT LAW CONSENT ORDER LCA-VISION |
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
)
In the Matter of ) FILE NO. 022 3098
)
LCA-VISION, INC. d\b\a LASIKPLUS, )
a corporation. ) AGREEMENT
) CONSENT ORDER
____________________________________)
The Federal Trade Commission ("Commission") has conducted an investigation of certain
and practices of LCA-Vision, Inc., a corporation ("proposed respondent"). Proposed respondent,
having been represented by counsel, is willing to enter into an agreement containing a consent order
resolving the allegations contained in the attached draft complaint. Therefore,
IT IS HEREBY AGREED by and between LCA-Vision, Inc., by its duly authorized officer,
and counsel for the Federal Trade Commission that:
1. Proposed respondent LCA-Vision, Inc. ("LCA"), is a Delaware corporation with its
office or place of business at 7840 Montgomery Road, Cincinnati, Ohio 45236. LCA provides
refractive surgery services under the name LasikPlus.
2. Proposed respondent admits all the jurisdictional facts set forth in the draft
3. Proposed respondent waives:
a. Any further procedural steps;
b. The requirement that the Commission's decision contain a statement of
and conclusions of law; and
c. All rights to seek judicial review or otherwise to challenge or contest the
order entered pursuant to this agreement.
4. This agreement shall not become part of the public record of the proceeding unless and
accepted by the Commission. If this agreement is accepted by the Commission, it, together with the
draft complaint, will be placed on the public record for a period of thirty (30) days and
about it will be publicly released. The Commission thereafter may either withdraw its acceptance
Page 1 of 6
agreement and so notify proposed respondent, in which event it will take such action as it may
appropriate, or issue and serve its complaint (in such form as the circumstances may require) and
decision in disposition of the proceeding.
SNIPPETS:
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