CORNEAT EVERPATCH

Description of Event or Problem

OVER THE PAST 6 MONTHS, 3 DIFFERENT OPHTHALMOLOGY 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 OR [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.