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Ophthalmic Devices Panel Meeting Summary for
November 8, 2000

DIVISION UPDATES
A. Ralph Rosenthal, M.D. – Director

Dr. Rosenthal announced the addition of three new members to the Division of Ophthalmic Devices. Dr. Dexiu Shi, vision scientist, Dr. Gene Hilmantel, optometrist and statistician, and Dr. Jeffrey Toy, molecular biologist.  He also announced the retirement of Dr. Morris Waxler, Chief, Diagnostic and Surgical Devices Branch.

BRANCH UPDATES

James F. Saviola, O.D. – Chief

Premarket Notification Devices (510(k)s clearances

1. K994320 for ChromaGen lenses, made by Cantor & Silver Limited (Northants, England) were cleared for market by the FDA on October 20, 2000.

• These are tinted prescription contact lenses intended as an optical aid for people with red-green color vision deficiencies. The lenses are designed to improve discrimination of specific colors that look the same to people with red-green color deficiencies.
• The lenses do not help wearers to see "new" colors or to perceive or appreciate colors as people with normal color vision do, but merely add brightness/darkness or hue differences to colors that are otherwise difficult or impossible to distinguish. However, discrimination of at least some other colors is actually impaired.
• ChromaGen lenses are not effective for people who are totally color-blind. The FDA marketing clearance for ChromaGen lenses is limited to red-green color deficiencies, and does not include yellow-blue deficiencies or total color-blindness.
• The ability to pass diagnostic color vision tests with ChromaGen lenses does not imply the ability to perform other color vision-related tasks. Therefore, ChromaGen lenses should not be used with diagnostic color vision tests in order to meet occupational performance requirements.
• Although ChromaGen lenses are the first such contact lenses to be cleared by the FDA for commercial marketing in the United States, the idea is far from new. The use of colored filters as an optical aid for color deficiency has been reported in the scientific literature since the 1850's,and at least two textbooks on color vision deficiencies contain entire chapters on the subject. A red-tinted hard contact lens known as the "X-Chrom" lens (a pre-amendment device) has been used for decades, and the FDA recently cleared filtered spectacle lenses for the same intended use.
• The FDA has determined that ChromaGen lenses are substantially equivalent to prescription contact lenses. The manufacturer conducted clinical studies to support a new indication for use as an optical aid for red-green color vision deficiencies.

2. Opti-Free EXPRESS Multi-Purpose Disinfecting Solution manufactured by Alcon Laboratories has recently received two marketing clearances to modify their directions for use to eliminate the rubbing step during the cleaning step of soft contact lens care.
1. K001214 was found Substantially Equivalent as of 10-Jul-2000 for lenses replaced 30 days or less.
2. The 30 day limitation was removed by K002589, found SubstantiallyEquivalent as of 23-Oct-2000. Soft contact lenses prescribed on any replacement schedule now have the modified directions for use in the labeling.

• The care steps included a rinse, followed by a 6 hour soak, followed by a final rinse.

• Language does appear in the labeling to advise users that additional products or procedures such as rubbing their lenses may be recommended by their eye care provider.

Premarket Approval Applications (PMAs)

Scott Medical Products - Perfluoropropane (C3F8) gas used as a tamponade within the eye to place pressure on a detached retina

• P900066/S003 Approved as Of 16-Mar-2000

Perfluropropane Process and Location Change

1) Change in Manufacturing Site;
2) Alternate Synthesis Route for Perfluoropropane; and
3) Changing Release Specification for the Perfluoropropane Gas.

• P900066/S004 - Approved as of 05-Sep-2000

Reviewed as a Special PMA supplement -Changes being effected.

Approval for a change to the toxicity test protocol to increase the number of samples to be tested from each production lot of perfluoropropane from one sample per lot to three samples per lot.

The update on the retinal gas in case there were some questions regarding availability of that product. It is a single manufacturer and the Agency is extremely sensitive to potential supply problems that may develop and result in shortages of the device.

Donna R. Lochner – Chief

• PMA approval – P990013 Staar Surgical, Co. - Collamer UV-Absorbing Posterior Chamber IOL on 4/2/2000. This IOL was not brought before the Panel because FDA determined that no new issues of safety or effectiveness were raised in this PMA. All PMAs that have been brought before the Panel from ICIB have received a final action by the Agency.

• Ms. Ashley Boulware has been named FDA Engineer of the Year, for the year 2001. This is a highly competitive award that recognizes the high caliber of her engineering expertise, particularly in the biomaterials and optical areas.

Jan C. Callaway, Microbiologist

Original PMA approved

June 30, 2000 P990078 Sunrise Hyperionä LTK System

Indications for Use: Temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction spherical equivalent (MRSE) where the magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.

PMA Supplements approved

April 14, 2000 – P970053/S2 Nidek EC-5000

Indications for Use: for the correction of myopia (-1.00 D to –14.00 D MSRE) with astigmatism < 4.00 D using laser in situ keratomileusis (LASIK)

September 22, 2000 – P970043/S7 Summit/Autonomous LADARVision®

Indications for Use: for up to +6.00D sphere and up to –6.00 cylinder for hyperopia, hyperopic astigmatism and mixed astigmatism using LASIK

October 18, 2000 – P930016/S10 VISX STAR S2 & S3 Excimer Laser System

Indications for Use: for hyperopia between +0.5 and +5.0D sphere with astigmatism from +0.5 to +4.0 D with maximum MRSE of +6.0D using photorefractive keratectomy (PRK)

December 17, 1999 – K993153 Intralase 600C Laser Keratome

May 2, 2000 – K000327 VISX WaveScan Wavefront Analysis System

May 19, 2000 – K000637 Autonomous Custom Cornea Measuring Device

June 27, 2000 – K993154 ARC Laser for the Dodick Laser Phacoemulsification System

October 20, 2000 – K991124 VisiJet Hydrokeratome (waterjet keratome)

PMA PRESENTATION

PMA P000026 – STAAR Surgical, Co.

AquaFlow® Collagen Glaucoma Drainage Device, Model CGDD-20
Indications for Use: for the reduction of intraocular pressure in patients with open-angle glaucoma uncontrolled on maximum tolerated medical therapy.

Panel Recommendation by vote: Approvable with Conditions (10 for, 1 against)

The conditions of approval:

• Modification of the indications for use of the device
• Revisions and additions to the device labeling
• Request for continued follow-up up to 2 years of the cohort presented

DISCUSSION OF A PART-MARKET APPROVAL STUDY
FOR 30-DAY CONTINUOUS WEAR CONTACT LENSES

The FDA presentation by Dr. Gene Hilmantel stated that the new contact lens materials with much higher oxygen transmission may have the potential for safer continuous wear for longer periods of time. However, the incidence of corneal ulcers is the main concern. Although a serious problem, the incidence of ulcers to too low to reliable determine the risk in a reasonable PMA study; therefore, it is the FDA position that the best way to address this concern is to require a "Post-Marketing Approval Study" of the risk posed by 30 days "continuous wear."

The panel was asked to deliberate on the following issues so that the Agency might obtain additional expertise from the medical community in preparing a guidance document for extended wear contact lens manufacturers.

• The definition of the study endpoint (type or types of ulcers) 
• What type of study would the panel recommend 
• The maximum acceptable risk of ulcer rate for statistical testing 
• What if any difficulty in getting enough ulcer incidences for an effective case-controlled study 
• The time frame for a case-controlled study 
• Type of clinical setting for implementation of the study

The Panel meeting tentatively scheduled for January 11-12, 2001 has been cancelled.

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)

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(Uploaded November 13, 2000)

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