FDA Public Health Notification:

Illegal Promotion of Contact Lenses
(You are encouraged to copy and distribute this Notification to contact lens users.)

To:       Eyecare Practitioners Who Dispense Contact Lenses

Purpose of this Notification

The Food and Drug Administration (FDA) is notifying eyecare practitioners, contact lens dispensers and
contact lens wearers of two illegal and potentially unsafe practices on the part of some contact lens
companies: (1) promoting the sale of tinted contact lenses that have not been evaluated by FDA for
safety or effectiveness; and (2) marketing orthokeratology lenses which have not been cleared for
marketing or approved as part of an investigational study by FDA. In both cases, firms have promoted
the contact lenses through various media, including the Internet, professional journals and trade
publications.

The color additives used in unapproved tinted lenses have not been evaluated for safety---we have no
information on their identity, chemical composition, stability or potential toxicity, and we do not know
whether they can cause irritation or injury to the eye. Additionally, FDA has not inspected the facilities
where these lenses are made to determine whether they are in compliance with good manufacturing
practices requirements.

The overnight use of orthokeratology contact lenses raises other safety concerns, since no reliable data
are presently available in the literature to evaluate this technique. Persons wearing orthokeratology
lenses overnight are considered to be at risk for mechanical effects on the cornea such as corneal
warpage or epithelial damage that could result in infection. Although the safety risks of interrupted
overnight wear may not be as great as continued overnight wear, there is still an increased risk of corneal
damage beginning with the first overnight period.

Because of these safety concerns, we are recommending that eyecare practitioners prescribe only
tinted lenses that have been approved or cleared for marketing by FDA, and orthokeratology
lenses that have either been cleared for marketing or approved for use as part of an investigational
study by FDA. We are also cautioning contact lens dispensers and users against using the services
of firms illegally marketing tinted lenses or orthokeratology lenses.

Regulatory Background

Tinted contact lenses, including piano or zero powered lenses, that are promoted for sale to the general
public are medical devices that are required to undergo clearance for safety and effectiveness by FDA
before they can be legally introduced or delivered into interstate commerce for commercial distribution.
The same holds true for orthokeratology contact lenses, including those manufactured from rigid gas
permeable (RGP) materials approved for overnight use. Daily wear lenses must receive marketing
clearance through FDA's premarket notification process (510(k)), and extended wear lenses must receive
marketing approval through an approved application for premarket approval (PMA).

Contact lens manufacturers and finishing labs who promote the sale of a specific orthokeratology lens
design to eyecare practitioners are subject to regulation by FDA. The same regulation applies to eyecare
practitioners who promote orthokeratology lenses outside the scope of their own practices---e.g., the
marketing and promotion of an unapproved product to other practitioners. Companies that promote a
service of tinting approved clear contact lenses for eyecare practitioners before or after the lenses have
been dispensed are also subject to regulation by FDA, since these companies are changing the
specifications of the approved lens.

Individual color additives used in the manufacture of tinted lenses are required to be listed in the Code of
Federal Regulation (CFR) for use in contact lenses in accordance with FDA's color additive regulation.
Before a color additive is listed as safe for use in coloring contact lenses, information about the additive
is carefully evaluated by FDA for biocompatability with ocular tissue. This review process effectively
eliminates the use of color additives that are toxic to eye tissue and those that are carcinogens.

Although orthokeratology has been practiced since the early 1960's, there has been only one contact lens
cleared for marketing by FDA for orthokeratology performed on a daily wear basis. The safety issues for
most daily wear orthokeratology lenses have generally been addressed by prior research and review of
the one lens cleared for marketing. FDA is not aware of any well-controlled clinical studies published in
the literature on the overnight use of orthokeratology lenses. The overnight use of lenses is not
considered daily wear and is considered extended wear since the lens is worn while the user is asleep.

An RGP lens designed for orthokeratology requires different testing and data than the traditional lens
design in order to establish safety and effectiveness. Some finishing labs have assumed---incorrectly---
that once the RGP lens material has been cleared for marketing by FDA, they may promote
orthokeratology lens designs made with that material. This is an illegal practice.

Misunderstandings about Custom Devices

Some companies that illegally market contact lenses have asserted that they are exempt from FDA
regulation because, they claim, they are making "custom devices." This is an incorrect interpretation of
FDA regulations; the agency has not considered tinted or orthokeratology contact lenses to be custom
devices as defined in 812.3(b) of the Federal Food, Drug, and Cosmetic Act.

We have decided to use enforcement discretion in our approach to manufacturers of theatrical (or special
effects) tinted lenses, provided the lenses are made for specified individuals for a single function-for
example, a specific character in a specific movie. However, this discretion does not include
manufacturers that promote the sale of similar tinted lenses to the general public. To date, only two
manufacturers have received FDA approval to market theatrical tinted lenses.

A licensed practitioner may individually design and prescribe an RGP orthokeratology lens for a
particular patient within the scope of his/her practice. However, eyecare practitioners who promote
orthokeratology in their practice should avoid making exaggerated and unsupported claims of safety or
effectiveness. Promotional material should include accurate, well-balanced statements explaining that
the effect of these lenses is temporary and limited. While we have decided to not intervene in this
practice at the present time, we do reserve the authority to take future action if data become available that
demonstrate an increased risk to public health associated with overnight use of orthokeratology lenses.

Reporting Adverse Events and/or Complaints

We are asking for your help in identifying complaints or injuries associated with use of tinted or
orthokeratology contact lenses If an adverse event, problem and/or complaint is observed, we request
that you report it directly to MedWatch, the FDA's voluntary reporting program, by phone at 1-800-
FDA-1088; by FAX at l-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600
Fishers Lane (HF-2), Rockville, MD 20850.

Getting More Information

Should you have questions about any of the items discussed in this letter, please contact James F.
Saviola, O.D., F.A.A.O., CDRH, Office of Device Evaluation, HFZ-460, 9200 Corporate Blvd.,
Rockville, MD 20850 or FAX 301-480-4201.

Additional copies of this Advisory can be found on the FDA WebPages at www.fda.gov/cdrh/safety.html
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              Sincerely yours,

D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological
Health Food and Drug Administration