inforMED
InjuryMTZ

OCU-GUARD

Received Oct 8, 2003

Report 2183620-2003-00030 · MDR key 488926

Device

Generic name

Orbital Implant Wrap

Model number

UNK

Catalog number

*

Lot number

UNK

Product problems

  • Melted
  • Device remains implanted

Patient

1 YR

  • Surgical procedure

Narrative

Description of Event or Problem

IN 2000 (EXACT DATE UKNOWN), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT TWELVE MONTHS POST-OP, PATIENT PRESENTED WITH 5 MM CONJUCTIVAL MELT OVER OCU-GUARD WRAP; PATIENT UNDERWENT INTERVENTION WITH FASCIA GRAFT. PATIENT POST-OP STATUS; PATIENT RETAINED ORBITAL IMPLANT.