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U.S. Department of Health and Human Services

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Ophthalmic Devices Panel Advisory Committee Meeting Brief Summary for May 23, 2003

BRANCH UPDATES


VITREORETINAL AND EXTRAOCULAR DEVICES BRANCH
James F. Saviola, O.D., Chief

In the Federal Register of April 4, 2003 (Volume 68, Number 65) FDA published a notice of availability for “Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert 86-10)”

The document includes FDA's guidance to FDA district offices for sampling or detention without physical examination of plano (zero-powered or noncorrective) contact lenses intended solely to change the appearance of the normal eye in decorative fashion, when these products are presented for importation into the United States

Section 201(i) of the Federal Food, Drug, and Cosmetic Act (the act) defines “cosmetic” to include “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance”. Decorative contact lenses are articles intended to be introduced into the eye, which is a part of the body, to beautify the wearer, promote the attractiveness of the wearer, or alter the wearer's appearance.

They are claimed to achieve this cosmetic result by changing the apparent color of the iris; by appearing to add a design to the iris (e.g., a professional sports team insignia); or by imparting a nonhuman or otherwise nonnormal appearance to the eye (e.g., cat's eye). Provided they are not marketed with claims that they effect physical or physiological change, decorative contact lenses are properly regulated as cosmetics under the act. The courts have read the statutory definitions employing the term “intended” to refer to specific marketing representations.

The fact that contact lenses are “devices” in the colloquial sense does not preclude cosmetic status under the act. FDA has previously determined that section 201(i) of the act applies to appearance-enhancing devices. Also, the fact that a product is intended to come into contact with the eye does not make it ineligible for cosmetic regulation

On October 22, 2002, FDA issued Import Alert 86-10, with respect to decorative contact lenses. The revised Import Alert 86-10 in the Federal Register does not cover contact lenses that are intended for vision correction or for prosthetic or other medical use.

There are some lenses currently on the market under cleared 510(k)s covering contact lenses intended for both vision correction use and for solely decorative purposes. The sponsors in these cases voluntarily included a plano lens in the range of corrective powers described in the 510(k) submissions. These products are regulated by FDA as medical devices under the act. Such control is not available for decorative contact lenses because these products are cosmetics under section 201(i) of the act.

Section 801(a) of the act authorizes FDA to refuse admission to articles that appear to be adulterated or misbranded. The guidance represents the agency's current thinking on the sampling or detention without physical examination of decorative contact lenses that appear to be adulterated or appear to be misbranded. Please read the FR Notice for a more detailed discussion of adulteration and misbranding of these products.

The FDA has taken a very strong position that it is necessary to have involvement of an eye care provider to fit and follow soft plano lens wearers to better manage risks associated with the lenses use. This position was described in a press release that warned consumers about the risk of permanent eye injury, and even blindness, associated with decorative contact lenses distributed without a prescription and without proper fitting by an eye-care professional.

The Center for Devices and Radiological Health also issued a Public Health Web Notification directed to healthcare professions that noted the significant risk of blindness and other eye injuries if non-corrective decorative/cosmetic lenses are distributed without an eye care professional’s involvement.

An article also appeared in the FDA’s Consumer magazine. The press release, web notification to professionals and the consumer article all included information on how to report problems to FDA under the MedWatch program.

The FDA’s MedWatch database subsequently recorded over 10 reports of decorative/colored contact lens events since the warnings last fall. That may not seem like many, but the total for previous years combined was equaled in a few months time. I would like to encourage all eye care professionals to document cases of contact lens related injuries via MedWatch.


Web links regarding Plano Contact Lenses


Federal Register of April 4, 2003 (Volume 68, Number 65):
http://www.gpo.gov/fdsys/pkg/FR-2003-04-04/pdf/03-8315.pdf


“Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert 86-10):
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0118-gdl0001.pdf


FDA Warns Consumers Against Using Decorative Contact Lenses Obtained Without a Prescription or Professional Fitting: http://www.fda.gov/bbs/topics/NEWS/2002/NEW00846.html


FDA Public Health Web Notification: Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription 

FDA Issues Warning on Decorative Contact Lenses, FDA Consumer magazine January-February 2003: http://www.fda.gov/fdac/features/2003/103_eyes.html


How to report problems to FDA under the MedWatch program.


FDA’s MedWatch database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.

 

 

DIAGNOSTIC AND SURGICAL DEVICES BRANCH
Everette T. Beers, Ph.D. - Chief

PMA Approvals
Three devices have been approved since the last panel meeting on August 1-2, 2002.

  • On May 23, 2003, the FDA approved P930016, Supplement 16, for the VISX Star S4 WaveScan® excimer laser for wavefront-guided laser in situ keratomileusis (LASIK) for the reduction or elimination of myopic astigmatism up to -6.00 diopters (D) mean refractive spherical equivalent (MRSE) with cylinder between 0.00 D and -3.00 D at the spectacle plane.

510(k) Clearances
Since August 2002, approximately thirty 510(k)s have been cleared.

Staff Changes
On January 1, 2003, the Branch lost the services of Quynh Hoang, an engineer and team leader in DSDB, who transferred to the Office of Surveillance and Biometrics in The Center for Devices and Radiological Health.

Additional Information
In April, 2003 form letters were sent to all IDE sponsors suggesting that, even if they had a previous PMA approval, they should meet with FDA prior to submitting their PMA. This pre-PMA meeting will provide an opportunity to pass along information regarding appropriate end points, stability information, safety and effectiveness tables and formatting for labeling of the PMA, with the hopeful result being a more manageable PMA for both FDA and the sponsor with fewer deficiencies identified during FDA review.


INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner, Chief

P010059 is the Morcher GmbH endocapsular tension ring used for capsular bag stabilization in patients with pseudoexfoliation syndrome or other situations of compromised zonules. This PMA was reviewed by the Ophthalmic Devices Panel in January 2002. The Panel recommended that the PMA was approvable with requests for, essentially, a complete reanalysis of the clinical data to resolve discrepancies in the PMA and to clarify information presented at the Panel meeting. At this time, the PMA has not yet been approved. The review team members are currently working with the sponsor to resolve the remaining issues.

PMA PRESENTATION

PMA P030002 – C & C VISION

Device: CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber
Accommodating Intraocular Lens

Indication for Use: For primary implantation in capsular bag for the correction of aphakia in an adult in whom a cataractous lens has been removed and who may benefit from improved near, intermediate and distance vision without spectacles.

Panel Recommendation by vote: Approvable with Conditions (unanimous 7-0)

Conditions of Approval

  1. Stratify existing patient satisfaction data by pupil size

    Among the conditions recommended were for the device labeling (physician, patient, or both) to include the following information

  2. The lens provides accommodative amplitude of about 1 diopter
  3. Data was not available on patients less than 50 years of age
  4. The percentage of patients having an uncorrected visual acuity of 20/40 was higher in bilaterally implanted eyes than in primary eyes
  5. Some patients will require glasses for reading

CLOSING ANNOUNCEMENT

The July 10-11, 2003 tentatively scheduled panel meeting has been cancelled.

Information on the status of the tentative September 11-12, 2003 meeting date will be available on the web by the end of July, 2003.

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

TRANSCRIPTS MAY BE PURCHASED FROM: (Written Request Only)

Neal R. Gross and Co., Inc.
1323 Rhode Island Avenue, NW
Washington, DC 20005-3701
(202) 234-4433 (voice), (202) 387-7330 (fax)
or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice), (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM:
(Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice), (301) 443-1726 (fax)

 

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