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July 1995

Excimer Laser Photorefractive Keratectomy: The Food and Drug Administration Panel Speaks

Author Affiliations

Los Angeles, Calif

Arch Ophthalmol. 1995;113(7):858-859. doi:10.1001/archopht.1995.01100070032019

On October 20, 1994, the Ophthalmic Devices Panel of the US Food and Drug Administration (FDA) (hereafter referred to as the Panel) met to consider whether to approve the application of one excimer laser manufacturer for photorefractive keratectomy (PRK) to correct myopia. The Panel consists of ophthalmologists and optometrists representing a spectrum from academia to private practice, plus nonvoting representatives of industry and consumers. The deliberations of the Panel members were followed closely by industry and physicians, as well as Wall Street. The possibility of surgically correcting ametropias, allowing "normal" vision without dependence on corrective lenses, is of great interest to the public, resulting in much attention from the lay press.

In many respects, the task before the Panel was a daunting one. Because the Panel has never given approval to a keratorefractive procedure (such as radial keratotomy or automated lamellar keratectomy), it has established no track record by which