OtherMTZ
OCU-GUARD
Received Oct 5, 2001 · Event occurred Jun 26, 2001
Report 2183620-2001-00018 · MDR key 357398
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
OG-1818SECatalog number
*
Lot number
525892
Product problems
- Explanted
- Replace
Patient
23 YR
- Surgical procedure, repeated
- Other (for use when an appropriate patient code cannot be identified)
- Organ Dehiscence
Narrative
Description of Event or Problem
IN 2001, PT UNDERWENT ENUCLEATION FOR A BLIND AND PAINFUL EYE. AN OCU-GUARD ORBITAL IMPLANT WRAP WAS APPLIED OVER THE MEDPOR PROSTHESIS. LATER IN 2001, THE PT PRESENTED WITH CONJUNCTIVAL DEHISCENSE WITH MULTIPLE AREAS OF ANTERIOR EXPOSURE. ABOUT THREE WEEKS AFTER THIS, THE OCU-GUARD AND MEDPRO PROSTHESIS WERE REMOVED AND REPLACED WITH AN ACRYLIC SPHERE. THE PT'S CONDITION IS REPORTED AS STABLE.