BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE TRIPLE ACTION CLEANING

    MDR report key: 11783241 · Received May 5, 2021

    Report

    Report Number
    MW5101206
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CLEAR CARE 3% HYDROGEN PEROXIDE AS REGULAR SALINE SOLUTION. THERE WAS A LENS ON THE COVER AND IT SAID "BRAND MOST TRUSTED BY EYE DOCTORS" I DID NOT EVEN KNOW THAT THIS TYPE OF LENS CLEANING EXISTS. I USED THE SOLUTION AS REGULAR SALINE SOLUTION. IT GIVE MY EYE A CHEMICAL BURN THAT LASTED FOR TWO DAYS. I HAD TO TAKE ONE DAY OFF WORK. THE LABELING/PACKAGING MAKES IT LOOK LIKE REGULAR SALINE SOLUTION AND ITS SOLD NEXT TO REGULAR SALINE SOLUTIONS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675876 CLEAR CARE TRIPLE ACTION CLEANING ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O