InjuryMTZ
OCU-GUARD
Received Aug 16, 1999 · Event occurred May 4, 1999
Report 2183620-1999-00020 · MDR key 236202
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
*Catalog number
*
Lot number
OGS-97J28-077
Product problems
- Explanted
- Implant extrusion
Patient
61 YR
- Extrusion
- Surgical procedure
- Surgical procedure, additional
Narrative
Description of Event or Problem
BILATERAL IMPLANTS OF OCU-GUARD INTO THE LOWER EYELIDS TO CORRECT RETRACTION (THIS IS AN UNAPPROVED USE OF THIS PRODUCT), IN 1999. IN 1999, THE OCU-GUARD WAS EXCISED FROM THE RIGHT LOWER LID AND IN 1999, IT WAS EXCISED FROM THE LEFT LOWER LID, BECAUSE THEY WERE EXTRUDING. THE PROBLEMS RESOLVED WITH EXCISION.