InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00021 · MDR key 488973
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
Patient
76 YR
- Capsular Contracture
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Description of Event or Problem
IN 2001, PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT FOUR WEEKS POST-OP PATIENT PRESENTED WITH 8 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. PATIENT UNDERWENT MULTIPLE INTERVENTIONS INCLUDING: CONJECTIVOPLASTY DERMIS GRAFT AND FINALLY REMOVAL OF ORBITAL IMPLANT AT NINE MONTHS POST-OP. PATIENT POST-OP STATUS: EYE SOCKET CONTRACTURE.