MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-01 for MORCHER COLOBOMA RING TYPE 96F manufactured by Morcher Gmbh.
[1203365]
Pt had cataract surgery with implantation of morcher 96f ring and pupilloplasty in 2008; surgery was uneventful and recovery good (right eye). Pt presented in 2009, with a retinal detachment right eye; both myself and the consulting retina surgeon do not feel the use of the device in related to the subsequent retinal detachment. Od retinal detachment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010943 |
| MDR Report Key | 1373659 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-04-28 |
| Date of Event | 2009-04-13 |
| Date Added to Maude | 2009-05-12 |
| 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 | MORCHER COLOBOMA RING |
| Generic Name | CAPSULAR RING WITH A PERTURE |
| Product Code | MRJ |
| Date Received | 2009-05-01 |
| Model Number | TYPE 96F |
| Lot Number | AJEBFD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORCHER GMBH |
| Manufacturer Address | KAPUZINERWEG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-01 |