MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-11-10 for BIO-EYE NI manufactured by Integrated Orbital Implants.
[17470998]
The physician reported exposures in pts who had received the coated bio-eye as part of a clinical investigation in europe.
Patient Sequence No: 1, Text Type: D, B5
[17597365]
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%. The distributor reported to the manufacturer that a surgeon in (b)(4) conducting a clinical investigation with the coated bio-eye had exposures in pts implanted with coated bio-eye. Surgeon has been unresponsive to follow up contacts to provided additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2010-00002 |
| MDR Report Key | 1907132 |
| Report Source | 08 |
| Date Received | 2010-11-10 |
| Date of Report | 2010-10-16 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-10-16 |
| Date Added to Maude | 2010-11-30 |
| 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 | 0 |
| 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 DR |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92130 |
| Single Use | 0 |
| 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 | 2010-11-10 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-11-10 |