MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-02 for BIO-EYE I00020S manufactured by Integrated Orbital Implants, Inc..
[16502096]
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%. Discussion of these cases with the reporting physician suggests a correlation with changes in the clinic's wrapping practices. It is unknown whether there is a causal relationship. We are anticipating the return of the explanted devices for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[16704543]
Physician's office reported that the doctor implanted a 20mm sterile implant. The pt now has an "exposed" implant. Pt returned to surgery for removal of implant in 2007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027377-2007-00008 |
| MDR Report Key | 974754 |
| Report Source | 05 |
| Date Received | 2008-01-02 |
| Date of Report | 2007-12-13 |
| Date of Event | 2007-12-14 |
| Date Mfgr Received | 2007-12-13 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-01-09 |
| 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 | 3 |
| 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, INC. |
| 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 |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2008-01-02 |
| Model Number | I00020S |
| Catalog Number | I00020S |
| Lot Number | 198037 |
| Device Expiration Date | 2013-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 943409 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-02 |