FDA Adverse Event
Other
Summary report: N
CVS DISINFECTING LENS CARE SOLUTION
MDR report key: 2013066
·
Received March 1, 2011
Report
- Report Number
- 2026940-2011-00001
- Event Type
- Other
- Date Received
- March 1, 2011
- Date of Event
- August 7, 2010
- Report Date
- August 16, 2010
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ONE PATIENT, AS DIAGNOSED BY PHYSICIAN, EXPERIENCED CORNEAL ABRASION IN HER LEFT EYE AFTER USING MEDICAL DEVICE, CVS DISINFECTING LENS CARE SOLUTION. PATIENT WAS PRESCRIBED TOBREX ANTI-BIOTIC (MEDICAL RECORDS ATTACHED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVS DISINFECTING LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. | 94943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |