BIO-EYE
Received Jan 2, 2008 · Event occurred Dec 14, 2007
Report 2027377-2007-00008 · MDR key 974754
Device
Generic name
Implant, Eye Sphere
Manufacturer
Integrated Orbital Implants, Inc.Model number
I00020SCatalog number
I00020S
Lot number
198037
Product problems
- Explanted
- Implant extrusion
Patient
48 YR
- Surgical procedure
Narrative
Additional Manufacturer Narrative
EXPOSURES ARE AN ANTICIPATED POSSIBLE COMPLICATION WITH THIS TYPE OF SURGERY. A REVIEW OF THE LITERATURE FINDS EXPOSURE RATES RANGING FROM 2.5% TO 21.6%. DISCUSSION OF THESE CASES WITH THE REPORTING PHYSICIAN SUGGESTS A CORRELATION WITH CHANGES IN THE CLINIC'S WRAPPING PRACTICES. IT IS UNKNOWN WHETHER THERE IS A CAUSAL RELATIONSHIP. WE ARE ANTICIPATING THE RETURN OF THE EXPLANTED DEVICES FOR FURTHER INVESTIGATION.
Description of Event or Problem
PHYSICIAN'S OFFICE REPORTED THAT THE DOCTOR IMPLANTED A 20MM STERILE IMPLANT. THE PT NOW HAS AN "EXPOSED" IMPLANT. PT RETURNED TO SURGERY FOR REMOVAL OF IMPLANT IN 2007.