MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-01 for ADVANCED MEDICAL OPTICS STABIL EYES STBL12US manufactured by Ophtec.
[1086075]
Capsular tension ring used in surgery had expired 2009-05. This was discovered after the surgery had alerted and the dr. Had the eye open and had to use it. We also called around town and they all were expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011725 |
| MDR Report Key | 1410810 |
| Date Received | 2009-07-01 |
| Date of Report | 2009-07-01 |
| Date of Event | 2009-06-17 |
| Date Added to Maude | 2009-07-13 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ADVANCED MEDICAL OPTICS STABIL EYES |
| Generic Name | CAPSULAR TENSION RING |
| Product Code | MRJ |
| Date Received | 2009-07-01 |
| Model Number | STBL12US |
| Lot Number | NA |
| Device Expiration Date | 2009-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPHTEC |
| Manufacturer Address | SCHWEITZOLAAN 15 GRONINGEN 9728NR NL 9728 NR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-01 |