EVERPATCH

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE EXTRUDED DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE INSTRUCTIONS FOR USE EFFECTIVE AT THE TIME OF USE INCLUDED A CONTRAINDICATION STATING THE "CORNEAT EVERPATCH SHOULD NOT BE USED IN SURGICAL SITES WHERE ACTIVE INFLAMMATION OF ANY CAUSE IS PRESENT, OR SITES WITH POOR PERFUSION." IMPLANTATION OF THE CORNEAT EVERPATCH WAS CONTRAINDICATED IN THIS PATIENT BASED ON THEIR HISTORY OF POOR OCULAR SURFACE WOUND HEALING. THE CURRENT DEVICE INSTRUCTIONS FOR USE IDENTIFIES THE FOLLOWING POSSIBLE COMPLICATIONS: "DETACHMENT OF THE DEVICE FROM SURROUNDING TISSUE IN CASE OF TRAUMA OR WHEN CHRONIC INFLAMMATION IS NOT ADDRESSED"; AND "CONJUNCTIVAL RETRACTION OR WOUND DEHISCENCE, WHICH MAY LEAD TO EXPOSURE OF THE DEVICE AND COULD REQUIRE A CORRECTIVE PROCEDURE". MANUFACTURER REFERENCE #: (B)(4).

Description of Event or Problem

ON AUGUST 18, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. A PATIENT WITH A HISTORY OF NEOVASCULAR GLAUCOMA, DIABETES, AND POOR OCULAR SURFACE WOUND HEALING UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) ON (B)(6) 2023. THE PATIENT SUBSEQUENTLY REQUIRED AGV REVISION SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE AGV WAS EXPLANTED AND REPLACED WITH AN AHMED CLEARPATH GLAUCOMA DRAINAGE DEVICE WHICH WAS COVERED WITH A CORNEAT EVERPATCH. APPROXIMATELY ONE MONTH FOLLOWING IMPLANTATION OF CORNEAT EVERPATCH, THE CONJUNCTIVAL WOUND DEHISCED, AND THE CORNEAT EVERPATCH SPONTANEOUSLY EXTRUDED FROM THE EYE. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC. NO SURGICAL REVISION WAS PERFORMED. NO PERMANENT IMPAIRMENT, INCLUDING VISION LOSS, WAS OBSERVED DURING THE 18-MONTH POSTOPERATIVE PERIOD.