InjuryHPZ
COATED BIO-EYE HA IMPLANT
Received Jun 22, 2009 · Event occurred May 26, 2009
Report 2027377-2009-00001 · MDR key 1406699
Device
Generic name
Implant, Eye Sphere
Manufacturer
Integrated Orbital Implants, Inc.Model number
I0016CLot number
63449
Product problems
- Implant extrusion
Patient
52 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PHYSICIAN REPORTED AN EXPOSURE ALONG SUTURE LINE OF COATED BIO-EYE THAT WAS IMPLANTED A YEAR EARLIER.
Additional Manufacturer Narrative
EXPOSURE IS AN ANTICIPATED COMPLICATION OF ORBITAL IMPLANT SURGERY. IT IS GENERALLY TREATED CONSERVATIVELY AND IS SURGICALLY CLOSED ONLY IN THE CASE OF LARGE EXPOSURES OR IF THE WOUND DOES NOT SPONTANEOUSLY CLOSE WITHIN A REASONABLE TIME PERIOD. IN THIS INSTANCE THE PHYSICIAN CONTACTED THE MFR FOR ADVICE, AND SURGICAL CLOSURE OF THE EXPOSURE WAS SUGGESTED.