FDA Adverse Event
Injury
Summary report: N
COATED BIO-EYE HA IMPLANT
MDR report key: 1406699
·
Received June 22, 2009
Report
- Report Number
- 2027377-2009-00001
- Event Type
- Injury
- Date Received
- June 22, 2009
- Date of Event
- May 26, 2009
- Report Date
- May 29, 2009
- Manufacturer
- INTEGRATED ORBITAL IMPLANTS, INC.
- Product Code
- HPZ
- PMA / PMN Number
- K003338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
PHYSICIAN REPORTED AN EXPOSURE ALONG SUTURE LINE OF COATED BIO-EYE THAT WAS IMPLANTED A YEAR EARLIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED BIO-EYE HA IMPLANT | IMPLANT, EYE SPHERE | HPZ | INTEGRATED ORBITAL IMPLANTS, INC. | I0016C | 63449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |