MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-07-11 for OPTISOL CORNEAL STORAGE MEDIA 50006-OPT manufactured by Bausch & Lomb.
[19939213]
This report has been completed by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[19950871]
Patient alleges vision loss resulting from an implanted donor cornea allegedly contaminated by this storage medium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2007-00802 |
| MDR Report Key | 879660 |
| Report Source | 00 |
| Date Received | 2007-07-11 |
| Date of Report | 2007-06-14 |
| Date of Event | 2005-11-22 |
| Date Mfgr Received | 2007-06-14 |
| Date Added to Maude | 2007-07-18 |
| 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 | 0 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTISOL CORNEAL STORAGE MEDIA |
| Generic Name | CORNEAL STORAGE MEDIA |
| Product Code | LYX |
| Date Received | 2007-07-11 |
| Catalog Number | 50006-OPT |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 859904 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14604 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-11 |