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July 1989

News and Comment

Author Affiliations

Director, Center for Devices and Radiological Health Food and Drug Administration Rockville, MD

Arch Ophthalmol. 1989;107(7):969. doi:10.1001/archopht.1989.01070020031023

This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables.


Dear Eyecare Practitioner: May 30, 1989

This is to inform you that the Food and Drug Administration is requesting manufacturers of cosmetic extended-wear soft contact lenses to indicate a recommended wearing time of 1 to 7 days in the product labeling, and to strengthen warnings about the risk of ulcerative keratitis and the importance of proper lens care in reducing this risk.

Our concern about the safety of wearing these lenses beyond 7 days is based partly on a multicenter study on ulcerative keratitis and contact lenses sponsored by the Contact Lens Institute (CLI) and conducted by Abt Associates Inc, of Cambridge, Mass, and the Massachusetts Eye and Ear Infirmary of Harvard Medical School. We commend the CLI for sponsoring this study and for making the results available. The principal findings of the CLI sponsored study are as follows:

  • • The annual incidence of ulcerative keratitis is estimated to be

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