MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-09 for DR. SCHMIDT SILICONE IRIS ARTIFICIAL IRIS manufactured by Dr. Schmidt Intraocularlinsen, Gmbh.
[1167481]
Anticipated intraocular lens dislocation, due to progressive zonulopathy and anticipated posterior capsular opacity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011891 |
| MDR Report Key | 1413881 |
| Date Received | 2009-07-09 |
| Date of Report | 2009-07-09 |
| Date of Event | 2009-04-08 |
| Date Added to Maude | 2009-07-20 |
| 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 |
| 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 | DR. SCHMIDT SILICONE IRIS |
| Generic Name | IRIS PROSTHETIC DEVICE |
| Product Code | NCK |
| Date Received | 2009-07-09 |
| Model Number | ARTIFICIAL IRIS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. SCHMIDT INTRAOCULARLINSEN, GMBH |
| Manufacturer Address | ST. AUGUSTIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-07-09 |