MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-18 for IRIS RETRACTOR * 4020 manufactured by Dutch Ophthalmic.
[17806001]
Iris retractors put in place within the eye for increase in working area for cataract removal. Cataract removed and intra-ocular implant placed. Attempt was made to remove iris retractors. Two were removed intact but two broke in process of removal. All pieces were removed. No injury to pt, but increase in operating time resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035229 |
| MDR Report Key | 593409 |
| Date Received | 2005-04-18 |
| Date of Report | 2005-04-07 |
| Date of Event | 2005-04-06 |
| Date Added to Maude | 2005-04-22 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIS RETRACTOR |
| Generic Name | IRIS RETRACTORS |
| Product Code | HNI |
| Date Received | 2005-04-18 |
| Returned To Mfg | 2005-04-07 |
| Model Number | * |
| Catalog Number | 4020 |
| Lot Number | 1000001799 |
| ID Number | * |
| Device Expiration Date | 2009-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 583254 |
| Manufacturer | DUTCH OPHTHALMIC |
| Manufacturer Address | 1 LITTLE RIVER ROADKINGSTON NH 03848 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-18 |