Food & Drug Administration (FDA)

FDA’s Role in LASIK Regulation

Lasers used for LASIK, PRK and other forms of laser refractive surgery are under the purview of the FDA; however, LASIK critics have long accused the FDA’s Division of Ophthalmic Devices of being little more than a regulatory pawn of the LASIK industry.

The FDA relied on short-term clinical trials of small patient populations conducted by financially-biased eye surgeons in its approval of LASIK. Long-term adverse effects of LASIK have since come to light.

Former FDA chief of ophthalmic devices, Morris Waxler, Ph.D., says the agency caved to pressure from the ophthalmology medical cartel and is calling for FDA-approval of LASIK to be withdrawn.

Former FDA Scientist Speaks Out

Meet a former FDA chief scientist who says that the agency was misled about the dangers of LASIK.

FDA Hearing

In response to public outcry of widespread problems with LASIK, the FDA called a special hearing on 4/25/2008: Listen to testimony of LASIK patient, Matthew Kotosovolos.

Listen to testimony of optometrist Edward Boshnick.

FDA Advisory Panel Chairman Rejects LASIK

FDA ADVISER who is not willing to risk Lasik because of the risk of LASIK complications.

Ms. Weiss, is a glasses-wearing FDA adviser who is not willing to risk LASIK.

From the article: The FDA advisers — a group of mostly glasses-wearing eye doctors — recommended that the agency make more clear the warnings it already provides for would-be Lasik patients… That’s a big reason why Weiss, the glasses-wearing ophthalmologist, won’t get Lasik even though she offers it to her patients. “I can read without my glasses and operate without my glasses, and I love that,” she said. “The second aspect is I would not tolerate any risk for myself.” Read USAToday article