PREFORMED OCU-GUARD SUPPLE

Description of Event or Problem

PRIOR TO THE EVENT DESCRIBED, THE PT WAS IMPLANTED ON 11/19/98 WITH A HYDROXYAPATITE OCULAR IMPLANT WRAPPED IN OCU-GUARD. THIS WAS TO TREAT THE PT FOR ANOPHTHALMOS, NO EYE, DUE TO AN ENUCLEATION WITHOUT IMPLANT WHICH HAD BEEN PERFORMED 36 YEARS PRIOR. NO CONCOMITANT SURGICAL PROCEDURE WAS PERFORMED ON THIS PT DURING THE TIME OF THIS IMPLANT SURGERY. WITHIN ONE WEEK OF THE IMPLANT SURGERY, THE PT PRESENTED WITH SIGNIFICANT ORBITAL INFLAMMATION, SWELLING AND EDEMA. THE PT WAS TREATED WITH STEROIDS ON 11/25/98 FOR THIS COMPLICATION. THE PT IS REPORTED AS STABLE AND DID NOT SUFFER ANY HARM DUE TO THIS COMPLICATION. THE SURGEON HAS REPORTED THAT THE USE OF OCU-GUARD, THE ORBITAL IMPLANT WRAP, CAN NOT BE DIRECTLY ATTRIBUTED TO THIS COMPLICATION. THE SURGEON REPORTED NO NEW TECHNIQUES OR PROCEDURES FROM THE OVER 100 ENUCLEATION SURGERIES HE HAS USED USING THE HYDROXYAPATITE OCULAR IMPLANTS WRAPPED IN OCU-GUARD.