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Advisory Committees

Ophthalmic Devices Panel Advisory Committee Meeting Brief Summary for October 3, 2003

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

Dr. Rosenthal introduced the new members of the Division of Ophthalmic and Ear, Nose and Throat Devices (DOED).

LCDR USPHS Lori Austin-Hansberry, R.N., M.S. – Project Manager

Lori Austin-Hansberry has joined the Intraocular and Corneal Implants Branch in the position of Project Manager. Among her duties will be ensuring that the Division meets MDUFMA product review goals. She is a LCDR in the Public Health Service, and has over 14 years experience as a registered nurse with a clinical, instructional and management background. Prior to joining FDA, she managed various clinical and administrative operations for the Montgomery County Dept. of Health and Human Services, most recently managing the Childhood Lead Poisoning and Prevention Program. She was also a Captain in the Air Force Reserves for 11 years. She obtained her nursing degree from Howard University and her Master’s degree in Healthcare Administration from Central Michigan University.

Ethan Cohen, M.D., Ph.D.

Dr. Cohen’s area of expertise is electrophysiology of the retina. His position is a shared hire with the Office of Device Evaluation. He comes to CDRH from Harvard University where he was a visiting professor in the Department of Molecular and Cell Biology. Prior to working at Harvard, Ethan was an Assistant Professor in the Department of Ophthalmology and Visual Sciences at the Yale Medical School. His Ph.D. in anatomy is from the University of Pennsylvania Medical School. As an Office of Science and Technology Staff Fellow, he will continue to research synaptic interactions of retinal cells. His review work with ODE will be in the area of retinal prosthetic devices that are reviewed in the Vitreoretinal and Extraocular Devices Branch of DOED.

Brad Cunningham

LTJG USPHS Bradley S. Cunningham is a biomedical engineer reviewer in the Intraocular and Corneal Implants Branch. He received his undergraduate degree from the University of Maryland in bioengineering focusing on biomedical instrumentation. After graduation, he was employed full-time at the Walter Reed Army Institute of Research in the Department of Neuropharmacology in the Division of Neurosciences. While there, he co-authored three papers; two recently published articles focusing on studying the therapeutic intervention window following transient cerebral ischemia and the delayed gene response.

Clay R. Buttemere, M.S.

Clay R. Buttemere is a biomedical engineer reviewer in the Diagnostic and Surgical Devices Branch. He received his B.S. degree in Engineering Science and Mechanics from Virginia Tech. After living and working for a year in the eastern European country of Macedonia, he and his wife moved to Nashville, TN where he enrolled in graduate studies in the Biomedical Engineering Department at Vanderbilt University. His research in the Biomedical Optics Lab at Vanderbilt involved using optical spectroscopy to assess tissue thermal damage in vivo. In May of 2003 he received the M.S. degree in Biomedical Engineering from Vanderbilt and in August of 2003 he began his career at FDA.

Joseph M. Blustein, M.D.

Dr. Joseph Blustein is a shared hire with Office of Surveillance and Biometrics and will be working on postmarket issues relating to Ophthalmic and ENT devices. He is a board certified Ophthalmologist and former Medical Director of the Wisconsin Peer Review Organization. He has two Masters Degrees: one in Epidemiology and one in Food Science. He serves on the Wisconsin Public Health Advisory Committee.

Srinivas Nandkumar, Ph.D.

Srinivas "Nandu" Nandkumar received his Bachelors degree in Electrical Engineering from Birla Institute of Technology and Science in Pilani, India. He then completed his M.S. degree in EE from Tulane University, New Orleans. He received a Ph.D. degree in EE from Duke University, North Carolina, where he specialized in Digital Speech and Signal processing. He has worked for the past ten years in the telecommunications and signal processing software industries such as Lockheed Martin, Hughes Network Systems, Armillaire Technologies, and Mercury Computer Systems. He is an author of several papers on Speech and Audio processing published in the journals and conference proceedings of the Institute of Electrical and Electronics Engineers. He has also been awarded six U.S. patents in the areas of voice compression and noise reduction in speech.

Antonio Pereira, MD

Dr. Pereira is a board-certified otolaryngologist-head and neck surgeon who joined the Division on Sept. 8, 2003. Following completion of his residency training in Otolaryngology-Head and Neck Surgery at the Puerto Rico School of Medicine and Affiliated Hospitals in 1986, he entered into private practice in Puerto Rico until moving his practice to Washington, D.C in 1997. In addition to his private practice, he has held academic appointments at the University of Puerto Rico and is currently the otolaryngology residency program director at the Washington Hospital Center (which hosts residents from Georgetown University). Since 1995 Dr. Pereira also has served part-time as a medical officer in the Center for Biologics Evaluation and Research where he has assisted in formulating regulations for the Human Tissue Program, and we are fortunate to have his diverse clinical and regulatory expertise with the ENT Devices Branch.


BRANCH UPDATES

INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner, Chief

In January, 2002, the panel reviewed PMA P010059, the Morcher GmbH endocapsular tension ring used for capsular bag stabilization in patients with pseudoexfoliation syndrome or other situations of compromised zonules. 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. We are in the final stages of review and we expect a decision in the near future.

In May 2003, the panel reviewed PMA P030002, the C&C Vision CrystaLens Accommodating Intraocular Lens. The Panel recommended that the PMA was approvable with requests that the patient satisfaction data be stratified by pupil size and that certain labeling revisions be made. The Panel recommended that the lens provides accommodative amplitude of about 1 diopter. Again, we are in the final stages of review and expect a decision in the near future.


PMA PRESENTATION

PMA P030016 – STAAR Surgical, Co.

Device: STAAR Myopic Implantable Contact Lens (ICL™)

Indication for Use: For the correction of moderate to high myopia between -3.0 diopters (D) to -20 D for placement in the posterior chamber of the phakic eye.

Panel Recommendation by vote: Approvable With Conditions - (8 for/3against)

Conditions of Approval

Included

  1. changes in the indications for use to include
    1. restricting the use of the device to patients with anterior chamber depth of 3 mm and greater;
    2. indicating the device for the reduction of myopia in patients with -15 to -20 diopters of myopia;
  2. recommending that 4 and 5 year endothelial cell density and rate of cataract formation data be collected in post market studies
  3. revisions to both patient and physician labeling
CLOSING ANNOUNCEMENT

The November 6-7, 2003 tentatively scheduled meeting 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)

Neal R. Gross and Co., Inc.
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Washington, DC 20005-3701
(202) 234-4433 (voice) (202) 387-7330 (fax)
or
Food and Drug Administration
Freedom of Information Staff (FOI)
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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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