FDA approves new LASIK device

Jul 12, 2007

The U.S. Food and Drug Administration has approved the first LASIK device designed to treat one eye for distance vision and the other eye for close vision.

LASIK -- laser in-situ keratomileusis -- is a procedure in which a surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with the laser, and then replaces the flap.

The new device -- CustomVue Monovision LASIK -- produces monovision correction in nearsighted (myopic) adults, with or without astigmatism, ages 40 years or older with normal age-related loss of ability to focus on near objects (presbyopia).

CustomVue is designed to correct all nearsightedness in the patient's dominant eye and only part of the nearsightedness in the non-dominant eye. That allows a person to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. The brain ultimately adjusts to the difference in perception between the eyes.

CustomVue Monovision LASIK -- manufactured by AMO/VISX Inc. of Santa Clara, Calif. -- is a permanent operation. Side effects can include light sensitivity, night driving glare, ghost images, double vision and visual fluctuation, the FDA said.

Copyright 2007 by United Press International

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