The CorNeat Everpatch and the Process of FDA Authorization
Notas do episódio
On September 5, 2025, the FDA issued a recall for the CorNeat EverPatch. Dr. Emily Schehlein is joined by Dr. Thomas V. Johnson to discuss his study on the early exposure and surgical revision rates of the CorNeat EverPatch. Later, Dr. Henry Jampel explains the difference between FDA clearance and FDA approval for medical devices.
Dr. Johnson coauthored the Ophthalmology article, "Early Postoperative Conjunctival Complications Leading to Exposure of Surgically Implanted CorNeat EverPatch Devices." Dr. Jampel cowrite the accompanying Commentary, "The CorNeat Everpatch and the Process of FDA Authorization."
Dr. Henry Jampel is an Associate Editor for Ophthalmology and the Editor-in-Chief for Ophthalmology Glaucoma. Dr. Thomas V. Johnson is an Associate Editor for Ophthalmology Science.
Early Postoperative Conjunctival Complications Leading to Exposure of Surgically Implanted CorNeat EverPatch Devices. Kanter, Jacob et al. Ophthalmology, Volume 132, Issue 7, 799 – 814.
The CorNeat Everpatch and the Process of FDA Authorization. Jampel, Risa; Jampel, Henry. Ophthalmology, Volume 132, Issue 7, 815 – 816.
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