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 EXPLANTED DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. 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". THE CURRENT INSTRUCTIONS FOR USE ALSO RECOMMENDS "IN THE SHORT TERM AFTER SURGERY, MORE FREQUENT FOLLOW-UP VISITS SHOULD BE CONDUCTED TO ENSURE PROPER WOUND HEALING." MANUFACTURER REFERENCE #: (B)(4).

Description of Event or Problem

ON JULY, 22, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. NO MIGRATION OF THE PATCH WAS OBSERVED AND THE WOUND WAS SEIDEL NEGATIVE (I.E., NO WOUND LEAK). THE PATIENT WAS BEING OBSERVED AND THE NEXT FOLLOW-UP VISIT WAS SCHEDULED FOR (B)(6) 2025. ON JULY 31, 2025, THE SURGEON PROVIDED THE FOLLOWING EVENT INFORMATION: ON (B)(6) 2025 THE PATIENT UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) IN THE LEFT EYE AND THE CORNEAT EVERPATCH WAS IMPLANTED IN THE SUPERIOR TEMPORAL QUADRANT. A FORNIX-BASED FLAP WAS USED AND NO CAUTERY OR MITOMYCIN-C (MMC) WAS APPLIED. VICRYL SUTURES WERE USED TO SUTURE THE EVERPATCH TO THE SCLERA AND INTERRUPTED VICRYL SUTURES WERE USED TO CLOSE THE CONJUNCTIVAL WOUND. POSTOPERATIVELY THERE WAS NO LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY. ON (B)(6) 2025, A CORRECTIVE PROCEDURE WAS PERFORMED WHERE THE EVERPATCH WAS EXPLANTED AND INVOLVED DISSECTION OF CONJUNCTIVAL GROWTH UNDERNEATH THE PATCH. THE AGV WAS THEN COVERED WITH TUTOPLAST PROCESSED SCLERA AND COVERED WITH ROTATIONAL CONJUNCTIVAL FLAP.