Laser Vision Centers, Inc.
This article was originally published in The Gray Sheet
Provider of laser vision correction equipment and support services is served with an administrative complaint and notice of opportunity for hearing by FDA's Center for Devices and Radiological Health relating to a March 1998 subpoena, LVC announces April 20. FDA action under administrative civil monetary procedures, launched April 4, proposes to assess civil monetary penalties totaling $5 mil. ($1 mil. for the company and each of four involved executives) for actions considered to have adulterated the devices. FDA's complaint relates to the company's use of "international" or "Bermuda cards" - electronic key card software enabling the use of the firm's excimer lasers to treat myopia cases beyond the range of FDA approval (greater than -6 diopters) prior to 1998. The company maintains that neither LVC nor other U.S. users of excimer lasers have used the cards since early 1998. Accordingly, LVC does not expect the action to have a material impact on the company. In 1996, the agency compelled Visx to modify software in its Star laser system so surgeons could not perform photorefractive keratectomy procedures on high myopia or astigmatism patients. Visx denies any knowledge of FDA's current actions
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