FDA Adverse Event
Injury
Summary report: N
COATED BIO-EYE HA IMPLANT
MDR report key: 2265528
·
Received September 23, 2011
Report
- Report Number
- 2027377-2011-00003
- Event Type
- Injury
- Date Received
- September 23, 2011
- Date of Event
- September 1, 2008
- Report Date
- August 30, 2011
- Manufacturer
- INTEGRATED ORBITAL IMPLANTS
- Product Code
- HPZ
- PMA / PMN Number
- K003338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPOSURES ARE AN ANTICIPATED COMPLICATION FROM ORBITAL IMPLANT SURGERY.
Description of Event or Problem · 1
THE REPORT IS OF AN INDIVIDUAL PRESENTING WITH AN EXPOSURE AND AN INFECTION. THE ANTERIOR PORTION OF THE IMPLANT WAS REMOVED AND COVERED WITH A SCLERAL PATCH GRAFT. THE PHYSICIAN ASSUMES THAT THE INFECTION OCCURRED BECAUSE OF THE EXPOSURE. THE IMPLANT IS NOW STABLE AND THE PATIENT IS INFECTION FREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED BIO-EYE HA IMPLANT | IMPLANT, EYE SPHERE | HPZ | INTEGRATED ORBITAL IMPLANTS | I0020C | 54304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |