OCU-GUARD
Received Jul 16, 1999 · Event occurred Apr 15, 1999
Report 2183620-1999-00014 · MDR key 232274
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
OG2020SFCatalog number
*
Lot number
517937
Product problems
- Explanted
Patient
36 YR
- Wound Dehiscence
- Surgical procedure
Narrative
Description of Event or Problem
PRIOR TO THE EVENT, THE SURGEON PERFORMED AN ENUCLEATION OPERATION ON 3/29/1999 ON THE PT'S LEFT EYE BECAUSE OF BLIND AND PAINTFUL EYE. A 20 MM ACRYLIC OCULAR IMPLANT SPHERE WRAPPED IN OCU-GUARD (ORBITAL IMPANT WRAP) WAS IMPLANTED FOLLOWING THE ENUCLEATION. THE PT HAD UNDERGONE MULTIPLE INTRAOCULAR PROCEDURES PRIOR TO THIS ENUCLEATION PROCEDURE. DESCRIPTION OF THE EVENT: 04/12/1999, THE PT PRESENTED WITH DEHISCENCE OF WOUND WITH EXPOSED OCU-GUARD (ORBITAL IMPLANT WRAP). ON 4/15/1999, THE SURGEON REMOVED THE OCU-GUARD WRAPPED IMPLANT. THE PT IS REPORTED TO BE IN EXCELLENT CONDITION AND DID NOT SUFFER ANY HARM DUE TO THIS COMPLICATION.