BIO-EYE
Received Feb 5, 2000
Report 2027377-2000-00001 · MDR key 261318
Device
Generic name
Ocular Implant
Manufacturer
Integrated Orbital Implants, Inc.Model number
NICatalog number
NI
Lot number
NI
Product problems
- Explanted
- Replace
- Implant extrusion
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Extrusion
- Surgical procedure, repeated
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PT REPORTED THAT AN IMPLANT THAT HAD BEEN PLACED IN 1995 BECAME EXPOSED IN 1999. PT SOUGHT CARE AND EVENTUALLY WAS ADVISED BY A DR THAT THE CONDITION MIGHT BE RESOLVED BY REMOVAL OF THE IMPLANT. THE IMPLANT WAS REMOVED AND REPLACED, ACCORDING TO THE PT, WITH AN ACRYLIC IMPLANT, REPORTEDLY IN 1999. FOLLOW-UP WITH THE SURGEON CONFIRMED THE REPLACEMENT. SURGEON STATES THERE WAS NO INDICATION ON DR'S PART THAT THERE WAS ANY PROBLEM FROM THE IMPLANT MATERIAL ITSELF. DR NOTED THAT ANY IMPLANT MATERIAL CAN HAVE EXPOSURE AND BE THE CAUSE FOR REMOVAL. DR REPORTED THAT A BACTERIAL CULTURE WAS TAKEN AND WAS NEGATIVE. DR REPORTED THAT PT HAS DONE WELL WITH REMOVAL OF THE IMPLANT AND PLACEMENT OF A SILICONE SPHERE.