InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00020 · MDR key 488969
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Device remains implanted
Patient
3 YR
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Description of Event or Problem
IN 2000, PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT EIGHT WEEKS POST-OP PATIENT PRESENTED WITH 8 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. PATIENT UNDERWENT ADDITIONAL INTERVENTION WITH FASCIA GRAFT. PATIENT POST-OP STATUS: PATIENT RETAINED ORBITAL IMPLANT.