MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-09 for STERILE COATED BIO-EYE I0018C manufactured by Integrated Orbital Implants.
[2057450]
Received an urgent safety notification report dated (b)(6) 2011, on coated bio-eye orbital implant from manufacturer, integrated orbital implants indicating that specific lot numbers were not labeled with an expiration date. Ioi reported that the specific lot numbers at our facility should have had a (b)(6) 2008 expiration date. One implant, the hydroxyapatite orbital implant and conformer 18mm cat# i0018c, serial number (b)(6), lot number 36307 was implanted (b)(6) 2010 after the expiration date given to us by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020971 |
| MDR Report Key | 2132619 |
| Date Received | 2011-06-09 |
| Date of Report | 2011-06-09 |
| Date of Event | 2010-10-19 |
| Date Added to Maude | 2011-06-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE COATED BIO-EYE |
| Generic Name | HYDROXYAPATITE IMPLANT AND CONFORMER 18MM |
| Product Code | HPZ |
| Date Received | 2011-06-09 |
| Catalog Number | I0018C |
| Lot Number | 36307 |
| Device Expiration Date | 2008-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | 11230 SORRENTO VALLEY RD. STE 135 SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-09 |