BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHOS AQUATECH 1 DAY SILICONE HYDROGEL DAILY DISPOSABLE LENSES

    MDR report key: 21219057 · Received January 22, 2025

    Report

    Report Number
    MW5165133
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 12, 2025
    Report Date
    January 16, 2025
    Manufacturer
    COOPERVISION, INC.
    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

    I OPENED TWO NEW PACKAGES OF COOPERVISION -2.25 ETHOSAQUATEC DAILY CONTACT LENSES. THESE ARE BRAND NEW LENSES THAT WERE ORDERED IMMEDIATELY AFTER MY EYE EXAM IN (B)(6) 2024. BOTH PACKAGES OF DAILY CONTACTS ARE BLURRY, CAUSED DRY EYES, ALONG WITH TROUBLE IN DRIVING, WORK, AND OTHER DAILY ACTIVITIES. THESE ARE THE SAME BRAND AND SAME PRESCRIPTION THAT I HAVE HAD FOR TWO TO THREE YEARS NOW WITHOUT AN ISSUE. THEY SEEM LIKE THEY MAY HAVE EITHER BEEN PACKAGED UNDER THE WRONG PRESCRIPTION OR HAVE SOME KIND OF RESIDUE ON THEM. I WENT BACK TO MY OPTOMETRIST TO GET A 5-DAY SUPPLY OF TRIAL LENSES UNDER THE SAME PRESCRIPTION AND THOSE WORK PERFECTLY, ALONG WITH THE OLD LENSES THAT I HAVE KEPT AT WORK IN CASE OF EMERGENCIES. I INSPECT AIRPLANE COMPONENTS FOR A LIVING SO HAVING DEFECTIVE OR POOR-QUALITY LENSES IS NOT ONLY A HAZARD TO ME IN MY DAY-TO-DAY LIFE BUT MAKE ME UNABLE TO DO MY JOB ETHICALLY AND SAFELY. COOPERVISION CASE HAS BEEN OPENED BUT THEY DO NOT WISH TO TAKE THE LENSES BACK FOR INSPECTION. REFERENCE REPORT #MW5165134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721741 ETHOS AQUATECH 1 DAY SILICONE HYDROGEL DAILY DISPOSABLE LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION, INC. (10):321086204700090020

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female