The FDA crackdown on unauthorized lasers should help both BEAM and VISX:
Wednesday October 22 4:54 PM EDT
FDA Warns Against Unapproved Eye Lasers
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said Wednesday it was taking action against clinics that were using unapproved lasers to treat nearsightedness and other eye conditions.
It said it had asked U.S. attorneys in several states to seize lasers from manufacturer Photon Data Inc., in Winter Park, Fla., and three clinics in Florida, Illinois and Georgia.
"Such unapproved lasers pose a risk to patients because their use could potentially cause serious eye injury," the agency said in a statement. "The manufacturer and eye clinics had all ignored prior warnings from FDA."
The lasers are used to treat vision problems such as myopia or nearsightedness and astigmatism in a procedure known as photo refractive keratectomy (PRK).
The surgeon permanently reshapes the cornea -- the outer layer of the eye -- by using the laser in bursts of ultraviolet light. "The effect is to flatten the cornea," the FDA said.
It said it was important that an approved product be used because the approval process included training the doctors in not only using the equipment, but in assessing patients.
It said U.S. marshals had seized $3 million worth of unapproved excimer lasers from Photon Data, as well as one made by Photon Data at Pro Cargo in Miami.
It also seized lasers from the offices of three medical doctors -- Trevor Woodhams of Woodhams Eye Clinic in Atlanta, Albert Neumann's Neumann Eye Institute in Deland, Fla., and Nicholas Caro St. George Corrective Vision Center in Chicago.
"Only two lasers are currently approved by FDA for refractive eye surgery," the statement added. "They are manufactured by Summit Technology Inc. of Waltham, Massachusetts and VISX Inc. of Santa Clara, California." |
