FDA Adverse Event
Injury
Summary report: N
CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM
MDR report key: 4045812
·
Received August 28, 2014
Report
- Report Number
- 2026940-2014-00007
- Event Type
- Injury
- Date Received
- August 28, 2014
- Date of Event
- August 18, 2014
- Report Date
- November 4, 2014
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INITIAL REPORT, THE DATE OF EVENT IS BEST ESTIMATED TO BE (B)(4) 2014. AWAITING RETURN OF COMPLAINT SAMPLE.
Description of Event or Problem · 1
COMPLAINANT FOR CR-14-095 STATED THAT AFTER USING MEDICAL DEVICE FOR EQUALINE HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSYTEM HE EXPERIENCED A BURNING SENSATION IN HIS EYES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527223 | CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. | 123259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |