BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASOFT CONTACTS

    MDR report key: 10513985 · Received September 9, 2020

    Report

    Report Number
    MW5096503
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 5, 2020
    Manufacturer
    CLERIO VISION
    Product Code
    LPL
    PMA / PMN Number
    K160344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHEMICAL BURN IN EYES; BEGAN EXPERIENCING A SEVERE BURNING SENSATION IN BOTH EYES, HEADACHES, AND EXTREME LIGHT SENSITIVITY THREE WEEKS AGO. THE DOCTOR PRESCRIBED ALLERGY MEDICATION. THE PAIN AND BURNING CONTINUE. I WAS UNAWARE THE SOURCE OF THE PAIN AT FIRST. IDENTIFIED THE CAUSE OF THE PAIN WAS THE CONTACT LENSES ON (B)(6) 2020; 1800 CONTACTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970476 AQUASOFT CONTACTS LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R