VCG's PMA for Laser In-Situ Keratomileusis Is Approvable, Panel Votes 6-0
This article was originally published in The Gray Sheet
Vision Correction Group's excimer laser system for in situ keratomileusis treatment should be approved, FDA's Ophthalmic Devices Panel voted unanimously (6-0) at a June 5 meeting in Rockville, Maryland. The panel also recommended that labeling include warnings about potentially increased risks to high myopic patients (-10.10 to -15.00 diopter) and the need for follow-up "enhancement" surgery in 20% of patients.
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