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VCG's PMA for Laser In-Situ Keratomileusis Is Approvable, Panel Votes 6-0

This article was originally published in The Gray Sheet

Executive Summary

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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