BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON DAILIES TOTAL 1

    MDR report key: 19998716 · Received August 15, 2024

    Report

    Report Number
    MW5158543
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN USING ALCON DAILIES TOTAL 1 CONTACTS, MULTIPLE CONTACTS WERE DEFORMED AND CAUSED EYE DISCOMFORT WHEN I TRIED TO USE THEM. THIS HAPPENED MANY TIMES WITH CONTACTS FROM THE BOX I WAS USING TODAY. THE CONTACTS WERE OFTEN FOLDED ON THEMSELVES WHEN I OPENED THE SINGLE USE SOLUTION PACKAGE EACH IS IN BEFORE USE. THE FOLDING RESULTED IN CREASES ON THE CONTACT PREVENTING THEM FROM FITTING CORRECTLY TO MY EYE. THIS RESULTED IN EYE DISCOMFORT AND BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682350 ALCON DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC. A5186985

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male