CORNEAT EVERPATCH

Description of Event or Problem

CORNEAT RECEIVED A VOLUNTARY MEDWATCH REPORT (#: MW5159333) WHICH STATED: "PATIENT UNDERWENT SURGERY ON THE RIGHT EYE. THE SURGERY INVOLVED COVERING OF EXPOSED GORE-TEX SUTURE ON THE OCULAR SURFACE, WHICH WERE PRESENT TO HOLD A SCLERAL SUTURED IOL (INTRAOCULAR LENSES) IN PLACE. THE SUTURES HAD ERODED THROUGH CONJUNCTIVA. THE SURGERY INVOLVED COVERING THE SUTURES WITH A CORNEAT EVERPATCH AND THEN CLOSING THE CONJUNCTIVA OVER IT. THE PATIENT WAS NOTED TO HAVE CONJUNCTIVAL RETRACTION AND EXPOSURE OF THE EVERPATCH AT POW7 (POST-OP WEEK#7). THE PATIENT IS CURRENTLY BEING OBSERVED." THE MANUFACTURER RECENTLY BECAME AWARE OF NEW INFORMATION WHICH LED TO THE CONCLUSION THAT THE CASE NOW MEETS THE DEFINITION OF A REPORTABLE EVENT. SPECIFICALLY, A RETROSPECTIVE CONSECUTIVE COMPARISON STUDY WAS PUBLISHED ONLINE WHICH REPORTED SAFETY OUTCOMES OF THE CORNEAT EVERPATCH AND HUMAN DONOR CORNEA. THE AUTHORS REPORTED THAT "ONE PATIENT WHO UNDERWENT REVISION FOR EXPOSURE OF AN ERODED IOL-FIXATION SUTURE AND KNOT EXHIBITED CONJUNCTIVAL DEHISCENCE AND EXPOSURE OF EVERPATCH WITHIN 15 DAYS AFTER SURGERY. THE EYE UNDERWENT A SECOND SURGICAL REVISION AT POSTOPERATIVE MONTH 7 BY EXPLANTING THE EVERPATCH, EXCHANGING THE IOL, ENSURING THAT THE NEW SCLERAL FIXATION SUTURE KNOTS WERE BURIED, AND CLOSING THE CONJUNCTIVA OVER THE SUTURES WITH NO PATCH MATERIAL." THIS CASE IS RELATED TO THE SUPPLEMENT REPORT FOR MDR#: 3029772936-2024-00004 AND PROVIDES ADDITIONAL DETAILS ON A SPECIFIC IDENTIFIABLE PATIENT FROM THE REPORTED CASES IN THE REFERENCED VOLUNTARY MDR.

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. AN INVESTIGATION IS UNDERWAY. 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." KANTER J, GARKAL A, CARDAKLI N, PITHA I, SABHARWAL J, SCHEIN OD ET AL. EARLY POSTOPERATIVE CONJUNCTIVAL COMPLICATIONS LEADING TO EXPOSURE OF SURGICALLY IMPLANTED CORNEAT EVERPATCH DEVICES. OPHTHALMOLOGY. 2025; MAR 3:S0161-6420(25)00141-1. EPUB AHEAD OF PRINT. DOI:10.1016/J.OPHTHA.2025.02.020. MANUFACTURER REFERENCE#: (B)(4).