MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-12-30 for OPTISOL-GS CORNEAL STORAGE MEDIA 50006-OPT manufactured by Bausch & Lomb Surgical.
[155477]
Information received from israel stated that primary graft failure occurred at one day post-operatively. The donor cornea was stored in the corneal storage media. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023366-1998-00060 |
| MDR Report Key | 204177 |
| Report Source | 01,08 |
| Date Received | 1998-12-30 |
| Date of Report | 1998-11-30 |
| Date Mfgr Received | 1998-11-30 |
| Device Manufacturer Date | 1998-06-01 |
| Date Added to Maude | 1999-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTISOL-GS CORNEAL STORAGE MEDIA |
| Generic Name | CORNEAL STORAGE MEDIA |
| Product Code | LYX |
| Date Received | 1998-12-30 |
| Model Number | NA |
| Catalog Number | 50006-OPT |
| Lot Number | 9816210305 |
| ID Number | NA |
| Device Expiration Date | 2000-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 198313 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 9342 JERONIMO ROAD IRVINE CA 926181903 US |
| Baseline Brand Name | OPTISOL-GS CORNEAL STORAGE MEDIA |
| Baseline Generic Name | CORNEAL STORAGE MEDIA |
| Baseline Model No | * |
| Baseline Catalog No | 50006-OPT |
| Baseline ID | * |
| Baseline Device Family | 86LYX |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K894162 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-30 |