MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-20 for OPTISOL-GS CORNEAL STORAGE MEDIA 50006-OPT manufactured by Bausch & Lomb.
[1206543]
Upon opening the vial containing the donor cornea the user detected a strong odor. The donor cornea was not used. The patient had been prepared for surgery including the use of anesthesia. The pt was rescheduled and the transplant was successfully performed at a later date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2009-00044 |
| MDR Report Key | 1375262 |
| Report Source | 06 |
| Date Received | 2009-02-20 |
| Date of Report | 2008-12-09 |
| Date of Event | 2008-12-09 |
| Date Mfgr Received | 2009-02-09 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-07-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263213 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTISOL-GS CORNEAL STORAGE MEDIA |
| Product Code | LYX |
| Date Received | 2009-02-20 |
| Returned To Mfg | 2008-12-11 |
| Model Number | NA |
| Catalog Number | 50006-OPT |
| Lot Number | W0004779 |
| ID Number | NA |
| Device Expiration Date | 2008-12-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-20 |