OPHTHALMIC DEVICES PANEL

One Hundred and Fifth Meeting

 

Gaithersburg Marriott, Salons A, B & C

9751 Washingtonian Blvd.

Gaithersburg, MD

 

OPEN SESSION

MAY 23, 2003

 

8:30 A.M. – 3:30 P.M.

 

8:30                  Call to Order                                                  Jayne S. Weiss, M.D. - Chair

           

                   Introductory Remarks                                           Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

                        ______________________________________________________

 

8:45 - 9:15                                OPEN PUBLIC HEARING

                    _______________________________________________

 

OPEN COMMITTEE SESSION

Jayne S. Weiss, M.D., Chair

 

9:15 - 9:30                                          DIVISION UPDATE

A. Ralph Rosenthal, M.D., Director

Division of Ophthalmic and Ear, Nose and Throat Devices

 

                                                           BRANCH UPDATES

James F. Saviola, O.D.

Chief, Vitreoretinal and Extraocular Devices Branch

Jan C. Callaway

Acting Chief, Diagnostic and Surgical Devices Branch

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

 

PMA P030002

 

9:30 - 10:30                                 SPONSOR PRESENTATION

 

CrystaLens™ Model AT-45

Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens

 

 

10:30 - 11:00                               Panel Questions for the Sponsor

 

11:00 - 11:20                                     FDA PRESENTATION

Donna R. Lochner – Introduction

Don Calogero– Team Leader

Bernard L. Lepri, O.D., M.S., M.Ed. – Clinical Reviewer

 

11:20 - 11:30                                    Panel Questions for FDA

 

11:30 - 11:35                         Additional Comments from the Sponsor

 

11:35 - 12:35                                                 LUNCH

 

12:35 - 3:30 p.m.                COMMITTEE DELIBERATIONS

 

Primary Panel Reviewers:

 

Anne L. Coleman, M.D., Ph.D.

Arthur Bradley, Ph.D.

 

PANEL  DISCUSSION OF P030002

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

 

COMMENTS FROM CONSUMER AND INDUSTRY REPRESENTATIVES

                        

FINAL PANEL COMMENTS

 

 

3:30 p.m.                                 OPEN MEETING ADJOURNED

 

 

 

 

 

 

 

 

NOTE:  15-MIN. BREAKS MAY BE GIVEN AT AN APPROPRIATE TIME DURING THE PROCEEDINGS