Orthokeratology Lens Labeling Should Note Visual Improvement - Panel
This article was originally published in The Gray Sheet
Executive Summary
Companies submitting premarket approval applications for rigid gas-permeable, extended-wear contact lenses for overnight orthokeratology (Ortho-K) should include in labeling a data grid showing the expected eyesight improvement likely to result from the process, FDA's Ophthalmology Devices Panel concluded at a Feb. 12 meeting in Rockville, Maryland.