MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-01 for MORCHER TYPE 14 * manufactured by Morcher Gmbh Stuttgart.
[349833]
Cataract surgery with planned piggyback iol's in high hyperope, small eye, and tight lid fissures. Unplanned emergency use of capsular tension ring intraoperatively due to zonular dehiscence. Postoperative slow healing with increased inflammation. Endophthalmitis presumptively diagnosed 3 weeks later, worked up, and treated with intravitreal antibiotic injections. Pt improved and uncorrected vision 2 months later was 20/30.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030733 |
| MDR Report Key | 505869 |
| Date Received | 2004-01-01 |
| Date of Report | 2004-01-01 |
| Date of Event | 2003-08-25 |
| Date Added to Maude | 2004-01-14 |
| 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 | 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 | 2004-01-01 |
| Model Number | TYPE 14 |
| Catalog Number | * |
| Lot Number | ADFBAA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 494738 |
| Manufacturer | MORCHER GMBH STUTTGART |
| Manufacturer Address | * * GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-01 |