BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFOCAL CONTACT LENSES

    MDR report key: 23621841 · Received November 21, 2025

    Report

    Report Number
    MW5179311
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 18, 2025
    Report Date
    November 19, 2025
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'VE BEEN WEARING THE SAME CONTACT LENSES AND STRENGTH FROM COOPERVISION FOR YEARS. WHEN I INSERTED A BRAND NEW CONTACT LENS IN MY RIGHT EYE, I NOTICED IT WAS BLURRY (THIS WAS A BRAND NEW BOX OF 6, BIOFINITY MULTIFOCAL, LOT (10) 10607170258011 MADE IN UK EXP 2028-05-31, PWR(POWER) -2.75 BC(BASE CURVE), 8.6, DIA(DIAMETER) 14.0, ADD(ADD'L POWER) +2.00 D, UPC 8 85409 31702 3). I THOUGHT I MAY HAVE INSERTED IT BACKWARDS BUT THE SAME RESULT. FORTUNATELY, I HAD ANOTHER BRAND-NEW LENS IN MY TOILETRY BAG AND INSERT IT WITHOUT ANY PROBLEM...CLEAR AS ALWAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578043 MULTIFOCAL CONTACT LENSES LENSES, SOFT CONTACT, EXTENDED WEAR LPM COOPERVISION, INC. BIOFINITY MULTIFOCAL (10) 10607170258011

    Patients

    Seq Age Sex Outcome Treatment
    1 Male LISINOPRIL-HCTX 20-12.5 MG TAB. | SIMVASTATIN 40 MG TABLET.