FDA Adverse Event Other Summary report: N

CLEAR CARE PLUS

MDR report key: 18446195 · Received January 3, 2024

Report

Report Number
MW5149766
Event Type
Other
Date Received
January 3, 2024
Date of Event
October 6, 2023
Report Date
January 3, 2024
Manufacturer
ALCON RESEARCH, LLC
Product Code
LPN
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

CLEAR CARE PLUS USED AS DESCRIBED ON SIDE OF BOX. PUT CONTACT LENS IN MORNING. ONE CONTACT FELT LIKE HAD SMALL GRIT. REMOVED, RINSED AND RUBBED CLEAN WITH SOLUTION. OUCH! VERY BAD BURNING SENSATION. EYE SLAMS SHUT OUT OF RESPONSE. MANAGED TO GET SOME WATER IN AND GET CONTACT OUT, BUT THAT'S VERY HARD TO DO WHEN YOUR EYE IS BURNING. THE NATURAL FEELING IS TO WANT TO CLAW YOUR CONTACT (AND EYE) OUT. THE FRONT OF THE BOX. (PLACED AMONG PLENTY OF OTHER REGULAR RINSE/SOAK PRODUCTS HAS NO WARNING. THE BACK BOX, DIRECTIONS FOR USE, HAS NO WARNING. EVEN THE WARNING ON ONE SIDE IS NOT CLEAR ENOUGH TO NOT USE AS A MANUAL RINSE IN YOUR HAND. HOPEFULLY MY EYE IS OK. ISMP,5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462/PHONE:(B)(4)/EMAIL:[email protected]. SUBMISSION ID (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1507341 CLEAR CARE PLUS ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC

Patients

Seq Age Sex Outcome Treatment
1 Unknown