Food and Drug Administration

OPHTHALMIC DEVICES PANEL
of the
MEDICAL DEVICES ADVISORY COMMITTEE

SLIDES

FDA Presenters:

James F. Saviola, O.D. – Introduction (pdf)
Gene Hilmantel, OD, MS – Fusarium Keratitis Outbreak Update                           
Bernard P. Lepri, OD, MS, MEd – What Do We Know About Contact Lens Wearers
Carol Clayton – Patient Labeling for Contact Lenses and Care ProductsJoseph C. Hutter, PhD – Lens and Solution Physical and Chemical Interactions
Myra Smith, MS – Microbiology Issues
Molly Ghosh, PhD, DABT – Lens – Solution Interactions:  Impact on Biocompatibility
Marc Robboy, OD – The Impact of Si-Hy CLs on Clinical Testing Methodology

Danica Marinac-Dabic, MD, PhD - Post Approval Studies Update (pdf)

CDC Guest Speakers:

2008-4363s1-03 - Jennifer Rabke Verani, MD, MPH, CDC, Multistate Outbreak of Acanthamoeba Keratitis Associated with Use of a Contact Lens Solution (pdf)

2008-4363s1-04 - Govinda S. Visvesvara, PhD, CDC, Resistance of Acanthamoeba Cysts to Disinfecting in Multiple Contact Lens Solutions (pdf)

Open Public Hearing

William Ehlers, MD (pdf)
Elmer Tu, MD (pdf)
Glenn Davies, OD (pdf)
Art Epstein, OD (pdf)
Dr. Simon Kilvington (pdf)
John M. Lally, PhD (pdf)
Jim Thimons, OD, FAAO (pdf)
Mark Wilcox, PhD (pdf)
David Hansen, OD, FAAO (DipCL), FCOVD (pdf)
Francis S. Mah, MD (pdf)
Louise A. Sclafani, OD, MS, PhD, and William J. Benjamin, OD, MS, PhD (pdf)
Charlotte Joslin, OD, FAAO (pdf)
Dwight Cavanagh, MD (pdf)

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