Laser Vision Centers to Pay $1.5 Million To Settle Lawsuit Brought by the FDA
Altered Eye Lasers Illegally
Laser Vision Centers Inc. agreed to pay the government $1.5 million over alterations it made to its laser eye-surgery equipment.
The Food and Drug Administration filed a complaint against the St. Louis, Mo., company in April, after learning the company altered the key cards that locked the laser into an FDA-approved range.
The changes allowed the machines to correct an unapproved range of vision problems. The company later received FDA approval for surgeries that were close to the range that the modified lasers allowed. The company called FDA limits on what the laser equipment can do "an unwarranted intrusion upon physicians' rights to practice medicine according to their best medical judgment."
Laser Vision said it was singled out by the FDA on a practice that was widespread and added that it has received no reports of injury to any patient because of the modified cards.
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