Description of Event or Problem · 0
OVER THE PAST 6 MONTHS, 3 (B)(6) DOCTORS HAVE PERFORMED A TOTAL OF 29 TUBE SHUNT IMPLANTATION SURGERIES USING THE CORNEAT EVERPATCH TO COVER THE TUBE. THIS IS AN FDA 510(K) CLEARED DEVICE MARKETED FOR USE IN CONJUNCTION WITH GLAUCOMA TUBE SHUNT IMPLANTATION OR TUBE REVISION PROCEDURES. AMONGST THIS COHORT OF PATIENTS, WE HAVE OBSERVED CONJUNCTIVAL RETRACTION AND EROSION WITH EXPOSURE OF THE EVERPATCH IN 9 PATIENTS (31%). OF THOSE, 4 HAVE COMPLETED OR ARE SCHEDULED FOR REVISION SURGERY DUE TO EITHER DISLOCATION OF THE EVERPATCH ONTO THE CORNEAL SURFACE OR PROGRESSIVELY INCREASING EXPOSURE OF THE EVERPATCH WITHOUT EPITHELIALIZATION. THIS RATE OF CONJUNCTIVAL RETRACTION AND PATCH EXPOSURE (REQUIRING RETURN TO OPERATING ROOM) IS DRAMATICALLY HIGHER THAN WHAT WE HAVE BEEN SEEING PREVIOUSLY WITH SPLIT THICKNESS CORNEAL HALF-MOON PATCH GRAFTS OR TUTOPLAST GRAFTS, AND WE ARE CONCERNED THERE MAY BE A PROBLEM WITH USING THIS DEVICE AS A PATCH FOR TUBE SHUNT SURGERY. I APOLOGIZE THAT I HAVE NOT PRE-POPULATED THE PATIENT INFORMATION THAT YOU ARE ASKING FOR INTO THIS FORM, BUT SINCE WE HAVE 9 PATIENTS, THERE WAS NO EASY WAY FOR ME TO DO THIS. IF YOU FOLLOW-UP WITH ME, I CAN PROVIDE A SPREADSHEET WHICH HAS THIS INFORMATION FOR ALL 29 PATIENTS THAT RECEIVED THE EVERPATCH, INCLUDING THE 9 THAT HAVE EXPERIENCED EXPOSURES.