BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE PLUS

    MDR report key: 14288548 · Received May 4, 2022

    Report

    Report Number
    MW5109539
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 3, 2022
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS WAS MY SECOND TIME USING THE PRODUCT. THE DATE OF MY EVENT HAPPENED (B)(6) 2022. MY CONTACTS SOAKED IN THE CLEAR CAR PLUS SOLUTION AND CASE FOR ABOUT 16 HOURS. I FOLLOWED THE INSTRUCTIONS THAT WERE ON THE PACKAGING AND THE SOLUTION BOTTLE. AFTER I STERILIZED MY HANDS, I WENT TO PUT MY LEFT CONTACT INTO MY LEFT EYE, THE CONTACT SEATED AROUND MY CORNEA, AND I EXPERIENCED AN EXTREME BURNING SENSATION. MY EYE BEGAN TO SPASM FROM THE BURN AND I HAD TO HOLD MY EYE OPEN AND SCRATCH AT MY EYE TO GET THE CONTACT OUT. THIS LASTED FOR ABOUT 45 SECONDS AND I EXPERIENCED TEMPORARY VISION LOSS IN MY LEFT EYE DURING THIS INCIDENT AND IMMEDIATELY AFTER. I FLUSHED MY EYE WITH WATER, HOWEVER 10 HOURS LATER MY EYE IS STILL SLIGHTLY BURNING AND VERY SORE. I WILL BE SEEKING MEDICAL ATTENTION BECAUSE OF MY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566640 CLEAR CARE PLUS ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female