FDA Adverse Event
Injury
Summary report: N
EQUALINE CLEANING AND DISINFECTING LENS CARE SOLUTION
MDR report key: 3078799
·
Received April 25, 2013
Report
- Report Number
- 2026940-2013-00002
- Event Type
- Injury
- Date Received
- April 25, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 25, 2013
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE COMPLAINANT'S COMPLETED QUESTIONNAIRE, KC PHARMACEUTICALS, INC. CONCLUDES THAT PRODUCT MISUSE IS THE ROOT CAUSE FOR THE COMPLAINANT'S EXPERIENCE. (B)(4): COMPLAINT SAMPLE COULD NOT BE RETRIEVED.
Description of Event or Problem · 1
ONE (1) PATIENT (B)(4) STATES THAT SHE EXPERIENCED A BURNING SENSATION IN THE EYES AFTER USING A MEDICAL DEVICE, EQUALINE CLEANING AND DISINFECTING LENS CARE SOLUTION. THE PATIENT MEDICAL RECORD IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179546 | EQUALINE CLEANING AND DISINFECTING LENS CARE SOLUTION | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |