9:30.A.M. – 3:30 P.M.

Main Conference Room

Office of Device Evaluation

9200 Corporate Boulevard

Rockville, MD

9:30 am Call to Order Joel Sugar, M.D. - Chair

Introductory Remarks Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

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9:45 - 10:15 am OPEN PUBLIC HEARING

Professor Brien A. Holden, Ph.D.

Director

The Cooperative Research Centre for Eye Research & Technology

Sydney, Australia

Associate Professor Deborah F. Sweeney, Ph.D.

Executive Director

The Cooperative Research Centre for Eye Research & Technology

Sydney, Australia

Dr. D. James Kerr

West Vision Center

Saskatoon, Saskatchewan, Canada

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Joel Sugar, M.D., Chair

10:15 - 10:25 am DIVISION UPDATE

A. Ralph Rosenthal, M.D., Director

Division of Ophthalmic and Ear, Nose, and Throat Devices

10:25 – 10:45 am BRANCH UPDATES

Everette T. Beers, Ph.D.

Chief, Diagnostic and Surgical Devices Branch

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

James F. Saviola, O.D.

Chief, Vitreoretinal and Extraocular Devices Branch

10:45 – 11:45 am SPONSOR PRESENTATION

(order of presentation may vary)

11:45 – 12 NOON Panel Questions for the Sponsor

12noon - 1:00 pm LUNCH

1:00 – 1:15 pm FDA PRESENTATION

James F. Saviola, O.D. – Introduction

Myra K. Smith – Team Leader

Bernard P. Lepri, O.D., M.S., M.Ed. - Clinical Review

1:15 – 1:30 pm Panel Questions for FDA

1:30 - 1:40 pm Additional Comments From the Sponsor

1:40 - 3:30 pm COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Janice M. Jurkus, O.D., M.B.A.

Alice Y. Matoba, M.D.

PANEL DISCUSSION OF P010019

to include FDA questions to the Panel

30-MINUTE OPEN PUBLIC HEARING SESSION

FDA – CLOSING COMMENTS (5 minutes)

SPONSOR – CLOSING COMMENTS (5 minutes)

Voting Options Read

PANEL RECOMMENDATION TAKEN BY VOTE

POLLING OF PANEL VOTES

FINAL PANEL COMMENTS

3:30 pm OPEN MEETING ADJOURNED