BIO-EYE
Received Jan 2, 2008 · Event occurred Nov 16, 2007
Report 2027377-2007-00009 · MDR key 974756
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
12 YR
- Surgical procedure
Narrative
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.
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.