MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-06-30 for BIO-EYE HA IMPLANT UNK manufactured by Intergrated Orbital Implants.
[1345099]
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.
Patient Sequence No: 1, Text Type: D, B5
[8557227]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2010-00004 |
| MDR Report Key | 1744657 |
| Report Source | 04 |
| Date Received | 2010-06-30 |
| Date of Report | 2010-06-30 |
| Date of Event | 1995-01-01 |
| Date Mfgr Received | 2010-05-28 |
| Date Added to Maude | 2012-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATALIE KENNEL, CONSULTANT |
| Manufacturer Phone | 8582594355 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Street | 12625 HIGH BLUFF DRIVE |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-EYE HA IMPLANT |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2010-06-30 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-30 |