MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-06 for * E3096L.9.50 manufactured by Storz Ophthalmics, Inc..
[174028]
After physician punched the donor cornea while placing it, it was niticed there were several small slivers of metal at the graft-host junction. They removed approx 8 slivers that measured less than a millimeter in length and were very thin from the junction and from the surface of the cornea. One was removed from the chamber and no others were seen. Upon inspection of the trephine, the edge appeared to be irregular. No other slivers have been seen. The edge of the transplant fit well into the bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015469 |
| MDR Report Key | 206756 |
| Date Received | 1999-01-06 |
| Date of Report | 1999-01-06 |
| Date of Event | 1998-12-13 |
| Date Added to Maude | 1999-01-21 |
| 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 |
| 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 | * |
| Generic Name | TREPHINE BLADE 9.50 MM |
| Product Code | HRH |
| Date Received | 1999-01-06 |
| Model Number | E3096L.9.50 |
| Catalog Number | * |
| Lot Number | S1137 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 200687 |
| Manufacturer | STORZ OPHTHALMICS, INC. |
| Manufacturer Address | 21 PARK PLACE BLVD. NORTH CLEARWATER FL 34619 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-06 |