FDA Adverse Event
Injury
Summary report: N
BIO-EYE
MDR report key: 974750
·
Received January 2, 2008
Report
- Report Number
- 2027377-2007-00006
- Event Type
- Injury
- Date Received
- January 2, 2008
- Date of Event
- December 13, 2007
- Report Date
- December 13, 2007
- Manufacturer
- INTEGRATED ORBITAL IMPLANTS, INC.
- Product Code
- HPZ
- PMA / PMN Number
- K982562
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
PHYSICIAN'S OFFICE REPORTED, THAT THE DOCTOR IMPLANTED A 20MM STERILE IMPLANT. THE PT NOW HAS AN "EXPOSED" IMPLANT. PT IS BEING MONITORED BUT DEVICE HAS NOT BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-EYE | IMPLANT, EYE SPHERE | HPZ | INTEGRATED ORBITAL IMPLANTS, INC. | I00020S | 198037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |