FDA Adverse Event
Other
Summary report: N
BIO-EYE HA IMPLANT
MDR report key: 1744657
·
Received June 30, 2010
Report
- Report Number
- 2027377-2010-00004
- Event Type
- Other
- Date Received
- June 30, 2010
- Date of Event
- January 1, 1995
- Report Date
- June 30, 2010
- Manufacturer
- INTERGRATED ORBITAL IMPLANTS
- Product Code
- HPZ
- PMA / PMN Number
- K891137
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT CONTACTED THE MANUFACTURER 15 YEARS POST EXPLANTATION IN ORDER TO REQUEST REFERRAL TO A PHYSICIAN IN HER AREA. NO FURTHER INFORMATION REGARDING THE EVENT IS AVAILABLE, AND WE WERE UNABLE TO CONFIRM THAT THE IMPLANT WAS AN IOI IMPLANT.
Description of Event or Problem · 1
PATIENT REPORTED THAT SHE RECEIVED AN HA ORBITAL IMPLANT ABOUT 15 YEARS AGO AND THAT HER BODY "REJECTED" THE IMPLANT. THE IMPLANT WAS REMOVED SHORTLY THEREAFTER. ACTUAL DATES OF IMPLANTATION AND EXPLANTATION ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-EYE HA IMPLANT | IMPLANT, EYE SPHERE | HPZ | INTERGRATED ORBITAL IMPLANTS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |