PREFORMED OCU-GUARD SUPPLE
Received Jan 29, 1999 · Event occurred Jun 19, 1998
Report 2183620-1999-00004 · MDR key 208592
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Explanted
- Replace
- Other (for use when an appropriate device code cannot be identified)
Patient
41 YR
- Surgical procedure, repeated
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
THE SURGEON REPORTED THAT ON 05/15/1998, HE PERFORMED AN ENUCLEATION PROCEDURE USING PREFORMED OCU-GUARD SUPPLE AS THE ORBITAL IMPLANT WRAP TO TREAT THE PT FOR A BLIND, PAINFUL EYE. ON 06/19/1998, THE PT PRESENTED WITH EXPOSURE OF THE HYDROXYAPETITE ORBITAL IMPLANT, WHICH THE PREFORMED OCU-GUARD SUPPLE IS USED TO COVER. ON 10/22/1998, THE SURGEON RECLOSED TENON'S CAPSULE AND CONJUNCTIVA OVER THE HYDROXYAPETITE ORBITAL IMPLANT WHERE IT WAS EXPOSED. THE SAME RECLOSURE PROCEDURE WAS PERFORMED ON 11/02/1998. ON 11/11/1998, THE SURGEON REMOVED THE PREFORMED OCU-GUARD SUPPLE ORBITAL WRAP AND THE IMPLANT. THE SURGEON DOES NOT KNOW IF THE PREFORMED OCU-GUARD SUPPLE CONTRIBUTED TO THE COMPLICATION THAT HIS PT EXPERIENCED. THE PT IS CURRENTLY DOING WELL AFTER REPLACEMENT WITH AN ACRYLIC SPHERE.