PREFORMED OCU-GUARD SUPPLE
Received Jan 29, 1999 · Event occurred Jun 26, 1998
Report 2183620-1999-00005 · MDR key 208589
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
OG-2020SFCatalog number
OG-2020SF
Lot number
UNK
Product problems
- Device remains implanted
- Other (for use when an appropriate device code cannot be identified)
Patient
57 YR
- Other (for use when an appropriate patient code cannot be identified)
- Nonresorbable materials, unretrieved in body
- Surgical procedure, additional
Narrative
Description of Event or Problem
THE SURGEON REPORTED THAT ON 04/17/1998, 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 06/26/1998, THE SURGEON RECLOSED TENON'S CAPSULE AND CONJUNCTIVA OVER THE HYDROXYAPETITE ORBITAL IMPLANT. ON 06/27/1998, THE PT PRESENTED WITH EXPOSURE OF THE OCU-GUARD AND THE SURGEON CLOSED WITH SUTURE. HE DID NOT REMOVE THE OCU-GUARD WRAPPED ORBITAL IMPLANT. HE DOES NOT KNOW IF THE OCU-GUARD CONTRIBUTED TO THE PT'S COMPLICATION. THE SURGEON THEN IMPLANTED A VAULTED CONFORMER PROSTHESIS SO THE IMPLANT WOULD NOT RUB.