InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00024 · MDR key 488981
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
- Melted
Patient
4 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 2001 (EXACT DATE UNKNOWN), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. A FIVE MONTHS POST-OP PATIENT PRESENTED WITH 20 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP; ORBITAL IMPLANT WAS THEN REMOVED. PATIENT POST-OP STATUS: NO IMPLANT IN EYE SOCKET.