FDA Adverse Event
Injury
Summary report: N
EQUALINE CLEANING AND DISINFECTING LENS CARE SYSTEM
MDR report key: 3148152
·
Received June 5, 2013
Report
- Report Number
- 2026940-2013-00003
- Event Type
- Injury
- Date Received
- June 5, 2013
- Date of Event
- May 5, 2013
- Report Date
- June 20, 2013
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT SAMPLE COULD NOT BE RETRIEVED.
Description of Event or Problem · 1
THIS IS A FOLLOW UP REPORT. THE INITIAL REPORT WAS SUBMITTED TO THE FDA ON (B)(4) 2013.
Description of Event or Problem · 1
ONE (1) PATIENT ((B)(6)) STATES THAT HE EXPERIENCED A BURNING SENSATION IN HIS EYES AFTER USING A MEDICAL DEVICE, AEQUALINE CLEANING AND DISINFECTING LENS CARE SYSTEM. THE PATIENT MEDICAL RECORD IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248277 | EQUALINE CLEANING AND DISINFECTING LENS CARE SYSTEM | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. | 109181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |