MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-22 for DR. SCHMIDT SILICONE IRIS ARTIFICIAL IRIS * manufactured by Dr. Schmidt Intraocularlinsen, Gmbh.
[1164669]
Anticipated intraocular lens dislocation, due to progressive zonulopathy and anticipated posterior capsular opacity.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5011609 |
MDR Report Key | 1407114 |
Date Received | 2009-06-22 |
Date of Report | 2009-06-22 |
Date of Event | 2009-06-18 |
Date Added to Maude | 2009-07-01 |
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 | 3 |
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 | 2009-06-22 |
Model Number | ARTIFICIAL IRIS |
Catalog Number | * |
Lot Number | 133028-918 |
ID Number | * |
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 | 2009-06-22 |