MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-25 for BIO-EYE NI manufactured by Integrated Orbital Implants.
[1518583]
Pt's mother reported that her son had received an orbital implant in 2005. This summer the ocularist noticed that the implant was exposed. Pt had surgery in 2009 to try to correct the exposure. Pt and doctor unhappy with the results of the surgery to correct the exposure. Device was not explanted.
Patient Sequence No: 1, Text Type: D, B5
[8498635]
Exposures are an anticipated possible complication with this type of surgery. A review of the literature finds exposure rates ranging from 2. 5% to 21. 6%. Exposures do not require the removal of the implant, so the implant was not explanted; so it could be returned for an investigation. Pt's mother complained to mfr to see what else could be done. Pt's mother did not want the doctor contacted, so we don't have any way to get more complete info regarding exact product model, size, lot or serial number of the implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2009-00002 |
| MDR Report Key | 1546841 |
| Report Source | 04 |
| Date Received | 2009-11-25 |
| Date of Report | 2009-10-30 |
| Date of Event | 2009-10-15 |
| Date Mfgr Received | 2009-10-30 |
| Date Added to Maude | 2009-12-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATIE CANNEL, CONSULTANT |
| Manufacturer Street | 12625 HIGH BLUFF DR. |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8582594355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-EYE |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2009-11-25 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-25 |