MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-01 for MORCHER * manufactured by Morcher.
[315340]
In 1997 a morcher capsular tension ring was placed in left eye. In 1999 it displaced in eye and a surgery was performed to remove it. When the ring displaced damage was done to the interior of the eye. Pt had 7 surgeries in the eye and no longer has vision in it. At the time the morcher ring was placed in the eye pt was not informed it was in a clinical trial and not yet fda approved. It was years later that as pt did some research pt found this out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028025 |
| MDR Report Key | 451745 |
| Date Received | 2003-04-01 |
| Date of Report | 2003-03-17 |
| Date of Event | 1997-03-31 |
| Date Added to Maude | 2003-04-07 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| 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 | MORCHER |
| Generic Name | CAPSULAR TENSION RING |
| Product Code | MRJ |
| Date Received | 2003-04-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 060397 |
| ID Number | TYPE 14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 440741 |
| Manufacturer | MORCHER |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2003-04-01 |