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U.S. Department of Health and Human Services

Advisory Committees

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Ophthalmic Devices Panel – January 13-14, 2000

 BRANCH UPDATES

VITREORETINAL AND EXTRAOCULAR IMPLANTS BRANCH

James F. Saviola, O.D. - Chief 

  1. Premarket Notification (510ks) recently cleared:
  • Purilens System contact lens cleaning and disinfecting unit, K991965 cleared October 1, 1999 is a device that contains a germicidal UV light in combination with a turbulent vibrating mechanism to clean and disinfect soft contact lenses. The subsonic agitation of lenses stored in the lower chamber of the device removes lens deposits and microorganisms. UV irradiation of the storage solution disinfects. The lenses are not directly exposed to the UV light.
  • Prosthetic soft contact lens, K992339, cleared November 18, 1999 is a lens that is partially or totally white opaque that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye. The pigment titanium dioxide is incorporated into the lens matrix. An artist then paints the lens with reactive dyes. This process is very much like a prosthetic eye that an ocularist would create.
There have been a number of other prosthetic lenses cleared during the past 14 months: Wesley Jessen, CL Tinters of Finland, Cantor and Silver from England and after market tinters Adventures in Colors & Colorsoft.
  • Softchrome Tints color enhanced tinted soft contact lens, K991995, cleared August 27, 1999. These are lenses tinted with a patented "In-office Tinting system" that consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives and other assorted chemicals to tint lenses that have been previously prescribed for a specific patient in the eye care practitioner’s office. This process offers a variety of colors and intensity levels, including a visibility tint. As with other after market tinting processes, except for the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

 

  1. The following information was released on December 28, 1999 by the National Institute of Environmental Health Sciences, of the National Institutes of Health:

In a step to reduce the number of guinea pigs used to test chemicals, the Consumer Product Safety Commission, the Environmental Protection Agency, the Occupational Safety and Health Administration, and the Food and Drug Administration are changing their procedures to accept results from a new test using mice rather than the traditional guinea pig test.

The National Toxicology Program, which is headquartered at the National Institute of Environmental Health Sciences, announced that these regulatory agencies have reported they are accepting test results using the Murine Local Lymph Node Assay.

 This alternate test, like the traditional one, is used to determine if a new chemical is likely to cause allergic contact dermatitis. The animal’s immunological response is determined by examination of lymph node tissue. The procedure can be done in a week as opposed to three to four weeks. Also, in most testing situations, fewer animals are required for each test.

In taking the new regulatory steps, the agencies concurred with a federally sponsored, independent scientific panel that the alternative assay could be used to identify whether or not chemicals may cause allergic contact dermatitis.

The scientific panel was convened by the new Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM was established to promote the scientific validation and regulatory acceptance of new tests that will provide improved prediction of adverse effects than currently used methods, and hopefully will aid animal welfare and reduce animal use. The lymph node assay was the first alternative test method to be reviewed using this process.

A Maximization Sensitization test such as this is recommended in the current contact lens guidance for materials that use new monomers that have not previously been used in currently marketed lenses, or for new UV absorbers that are not currently used. It is also recommended for lens care products that use new ingredients.

 

DIAGNOSTIC AND SURGICAL DEVICES BRANCH

Morris Waxler, Ph.D. - Chief

  • Microkeratome issues were discussed at the last meeting of the panel. We are planning to expand the section on blades in our guidance based on the comments received at that meeting. In addition, the panel suggested that the guidance identify standardized labeling information concerning the performance of keratomes. The major impediment to this suggestion is the lack of standardized methods for evaluating the performance of keratomes. We would appreciate any assistance in developing standardized test methods.
  • FDA has cleared a premarket notification (a 510k) to market a laser microkeratome, K993153. The manufacturer is Intralase, Inc. This medical device has two product codes: GEX for lasers; and HNO for keratomes. The Division of Ophthalmic devices reviewed this application with our colleagues in the Division of General and Restorative Devices, who cleared the application.
  • The FDA has received a number of media inquiries about Colormax eyeglass lenses, which are being promoted widely as a way to correct color blindness. Some of the claims in these promotions are false and misleading, and they exceed the labeling restrictions that the FDA has placed on this device. There is a FDA talk paper available on our web site.
  • We have approved seven premarket approval applications (PMAs) for lasers for refractive surgery in the last 3 months:

P970056 – September 28, 1999 - Bausch & Lomb’s KERACOR 116 laser for the PRK treatment of myopia with or without astigmatism: -1.50 to -7.00D of SPH and < -4.50 D CYL

P970053/S1 – September 29, 1999 - Nidek EC-5000 laser for the PRK treatment of myopia with or without astigmatism: -1.00 to -8.00 SE and -0.50 to -4.00 CYL

P930034/S12 – October 21, 1999 - Summit Apex Plus laser for the PRK treatment of hyperopia: +1.5 to +4.0 D SPH with <-1.00D CYL

P930034/S13 – October 21, 1999 - Summit Apex Plus laser for the LASIK treatment of myopia: 0.00 to –14.00D SPH and 0.5 to 5.0 D CYL

P980008 – November 9, 1999 - LaserSight LaserScan LSX Laser System for the PRK treatment of myopia less than –6.0D

P990010 – November 19, 1999 - CRS for the VISX Star S2 laser for the LASIK treatment of myopia with or without astigmatism: -1.00 to –14.00D SPH and 0.5 to 5.0 D CYL

P970049 – December 16, 1999- Dishler Excimer Laser System for the LASIK treatment of myopia (-0.5 to –13.0D) with or without astigmatism (-0.5 to –4.0D)

  • Currently there are 12 PMAs and supplements for lasers for refractive surgery under review (89 documents). This increase in the number of PMAs under review was accompanied by a decrease in the number of investigational device exemption (IDE) submissions. Manufacturers submitted 20 IDEs (53 documents) for clinical studies of refractive lasers. Sponsor-investigators submitted 16 IDEs (40 documents) for clinical trials for refractive lasers. There were very few new sponsor-investigator submissions for IDEs for refractive lasers and no new submissions from so-called "black box" lasers.

INTRAOCULAR AND CORNEAL IMPLANTS BRANCH

Donna R. Lochner, - Chief

  1. The Bausch and Lomb PMA P990014, reviewed by the Panel on July 23, 1999, for the Hydroview™ posterior chamber intraocular lens was approved on November 12, 1999.
  2. The Intraocular Lens (IOL) Guidance document was released for comment to the Panel and the public in July of 1999. This is the version that contains the updated IOL grid of historical clinical data. The formal comment period ended yesterday, January 12, 2000. We expect to be receiving and reviewing any remaining comments in the next few weeks and finalizing the document in the near future.
  3. The Branch continues to work closely with the American National Standards Institute (ANSI) to develop standards for ophthalmic products. Future meeting, which are open to interested persons, include one prior to the Association for Research in Vision and Ophthalmology (ARVO) meeting in Ft. Lauderdale, Florida on March 5 - 6, 2000. At the meeting an ANSI standard for multifocal IOLs and refractive implant devices will be drafted. ANSI will also be meeting prior to the American Society for Cataract and Refractive Surgery (ASCRS) meeting on May 18-19, 2000. This meeting will continue to work on the refractive implants and IOL standards.
Of note, is the ongoing work with ANSI on refractive implants. Subgroups have been formed to address requirements and testing for endothelial cell counts and cataract formation. FDA’s guidance is being developed along with the standards effort, as it is our goal to harmonize as much as possible with national and international standards. We plan to bring drafts of the guidance to the panel for comment as these efforts continue.

PMA PRESENTATION

PMA P990078 – Sunrise Technologies, Inc.

Hyperion™ Holmium Laser System for the reduction of hyperopic refractive error in subjects with +0.75 to 2.50 D of Mean Refractive Spherical Equivalent (MRSE) and < 0.75 D of astigmatism at the spectacle plane, where the magnitude of correction diminishes over time.

Panel Recommendation by vote: Approvable with conditions, 9-0

The conditions of approval:

The indications for use statement should be revised to state that the device is for the temporary reduction of hyperopic refractive error

REVISE PATIENT AND PHYSICIAN LABELING:

 ADD WARNING: The treatment effect decreases over time.

ADD WARNING: Data on effect of retreatment with the Sunrise laser or other refractive surgical procedures is insufficient at the present time. Available data suggests that the retreatment effect with the Sunrise laser also decreases over time. Outcomes of multiple retreatments are unknown.

ADD SPECIFIC DATA on the numbers of patients needing spectacle or contact lenses refractive correction after having received laser thermal keratoplasty (LTK).

ADD INFORMATION on the likelihood of developing postoperative symptoms, e.g. difficulty with night driving, glare, and photophobia. Include a statement that information on the frequency of these symptoms within the first 6 months after the LTK procedure is not available

CLARIFY DESCRIPTION in patient labeling regarding the anatomy of the eye, over-correction (induced myopia), and presbyopia

PROVIDE ADDITIONAL DATA ON:

Satisfaction levels and treatment outcomes stratified by age

Retreatment outcomes

RECLASSIFICATION

Reclassification 513(e) Petition, Docket number 99P-2171/CCP 1, filed 6/25/99

Device: ARTIFICIAL EYE CARE PRODUCTS used for the lubricating and/or cleaning of artificial eyes

Panel Recommendation by vote: Class II

CLASSIFICATION

Device: IMPLANTABLE EYELID WEIGHTS for the management of incomplete eyelid closure

Panel Recommendation by vote: Class II

Device: EXTERNAL EYELID WEIGHTS for the management of incomplete eyelid closure

Panel Recommendation by vote: Class II exempt

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)

Miller Reporting Company, Inc.
507 C Street, N.E.
Washington, D.C. 20002

(202 546-6666

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)