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Laser Vision Settles FDA Complaint

Photonics.com
Jan 2001
ST. LOUIS, Jan. 16 -- Laser Vision Centers Inc., provider of excimer lasers and related equipment for the treatment of nearsightedness, farsightedness and astigmatism, has settled a complaint that was issued by the Center for Devices and Radiological Health of the US Food and Drug Administration. The complaint charged that international cards software used by Laser Vision Centers allowed the company's excimer lasers to perform laser eye surgeries for higher myopia cases (greater than -6.0 diopters) than what was initially approved by the FDA. The FDA ultimately approved the use of an excimer laser for higher myopia cases in January 1998.Under the terms of the settlement agreement, the company and its executives will pay a total of $1.5 million to settle all claims in the complaint. The FDA had sought payment of as much as $5 million. The settlement contained no finding of any wrongdoing on the part of the company or any of its executives.


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