MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-08 for CVS ONE STEP CLEANING AND DISINFECTING SOLUTION * manufactured by Sauflon Pharmaceuticals Ltd.
[308929]
Customer experienced bad burning and redness of the eyes, went to the doctor and was given eye drops to clear the redness. Pt admitted not allowing their lenses to soak for six hours before they inserted them into their eyes and not reading the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438562-2004-00001 |
| MDR Report Key | 520731 |
| Date Received | 2004-04-08 |
| Date of Report | 2003-10-03 |
| Date of Event | 2003-09-01 |
| Date Facility Aware | 2003-10-02 |
| Report Date | 2003-10-03 |
| Date Added to Maude | 2004-04-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS ONE STEP CLEANING AND DISINFECTING SOLUTION |
| Generic Name | CLEANING AND DISINFECTING LENS CARE SYSTEM |
| Product Code | MRC |
| Date Received | 2004-04-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 56221 |
| ID Number | UPC #05048037263 |
| Device Expiration Date | 2006-08-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 509840 |
| Manufacturer | SAUFLON PHARMACEUTICALS LTD |
| Manufacturer Address | * TWICKENHAM, MIDDLESEX UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-08 |