FDA Adverse Event
Injury
Summary report: N
EQUALINE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM
MDR report key: 3645948
·
Received February 25, 2014
Report
- Report Number
- 2026940-2014-00004
- Event Type
- Injury
- Date Received
- February 25, 2014
- Date of Event
- February 4, 2014
- Report Date
- February 25, 2014
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLE NOT AVAILABLE.
Description of Event or Problem · 1
ONE (1) PATIENT (B)(6) STATED THAT SHE EXPERIENCED A BURNING SENSATION IN THE EYES AFTER USING MEDICAL DEVICE, EQUALINE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM. PATIENT CLAIM TO HAVE USED IT THINKING IT WAS SALINE SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116413 | EQUALINE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |