Excimer laser seizure
This article was originally published in The Gray Sheet
Executive Summary
Photon Data, Inc. agrees to condemnation of 10 unapproved ophthalmic excimer lasers and related components valued at $13 mil. under a consent decree with FDA, the agency states in a Nov. 16 release. The Winter Park, Florida firm also will recondition various laser components under FDA supervision. FDA had seized the lasers, which were marketed without approval and used for myopia and astigmatism correction procedures, in 1997. Two similar lasers continue to be operated by physicians under investigational device exemptions that do not involve PDI. The company has agreed not to wrongly distribute or falsely indicate lasers in the future, and has agreed to place $100,000 in escrow to pay potential fines of $25,000 for each future violation
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