FDA Adverse Event
Other
Summary report: N
CVS DISINFECTING LENS CARE SOLUTION
MDR report key: 2740832
·
Received September 12, 2012
Report
- Report Number
- 2026940-2012-00008
- Event Type
- Other
- Date Received
- September 12, 2012
- Date of Event
- July 23, 2012
- Report Date
- August 27, 2012
- Manufacturer
- K. C. PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
REASON FOR REPORTING AFTER 30 DAYS: KC PHARMACEUTICALS, INC BECAME AWARE OF PATIENT, (B)(4) ON (B)(4) 2012.
Description of Event or Problem · 1
ONE PATIENT (1) STATES THAT SHE EXPERIENCED A BURNING SENSATION IN HER EYES AFTER USING A MEDICAL DEVICE, DVS DISINFECTING LENS CARE SOLUTION. PATIENT MEDICAL RECORD IS NOT AVAILABLE THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVS DISINFECTING LENS CARE SOLUTION | LPN | K. C. PHARMACEUTICALS, INC. | 107667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |