inforMED
InjuryMTZ

OCU-GUARD

Received Nov 14, 2003

Report 2183620-2003-00040 · MDR key 495778

Device

Generic name

Orbital Implant Wrap

Model number

UNK

Catalog number

*

Lot number

UNK

Product problems

  • Explanted

Patient

UNKNOWN

  • Pain
  • Surgical procedure

Narrative

Description of Event or Problem

PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE OBRITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT 1 YEAR POST-IMPLANT PT PRESENTED WITH CHRONIC PAIN IN EYE SOCKET, REQUIRING REMOVAL OF THE DEVICE.