MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2000-02-05 for BIO-EYE NI manufactured by Integrated Orbital Implants, Inc..
[205782]
Pt reported that an implant that had been placed in 1995 became exposed in 1999. Pt sought care and eventually was advised by a dr that the condition might be resolved by removal of the implant. The implant was removed and replaced, according to the pt, with an acrylic implant, reportedly in 1999. Follow-up with the surgeon confirmed the replacement. Surgeon states there was no indication on dr's part that there was any problem from the implant material itself. Dr noted that any implant material can have exposure and be the cause for removal. Dr reported that a bacterial culture was taken and was negative. Dr reported that pt has done well with removal of the implant and placement of a silicone sphere.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027377-2000-00001 |
| MDR Report Key | 261318 |
| Report Source | 04,05 |
| Date Received | 2000-02-05 |
| Date of Report | 2000-02-05 |
| Date Mfgr Received | 2000-01-11 |
| Date Added to Maude | 2000-02-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 12526 HIGH BLUFF DR, #300 |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8587923565 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-EYE |
| Generic Name | OCULAR IMPLANT |
| Product Code | HPZ |
| Date Received | 2000-02-05 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 253082 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Address | 12526 HIGH BLUFF DR, #300 SAN DIEGO CA 92130 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-05 |