BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFINITY TORIC

    MDR report key: 24800423 · Received April 7, 2026

    Report

    Report Number
    MW5186428
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 2, 2026
    Manufacturer
    COOPERVISION INC.
    Product Code
    LPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LENS ARE DEFECTIVE AND CONTAIN NO REFRACTION FOR VISION. PATIENT CODE: 4582. DEVICE CODE: 2588, 1631. REFERENCE REPORT MW5186427.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6928 BIOFINITY TORIC LENSES, SOFT CONTACT, EXTENDED WEAR LPM COOPERVISION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male