BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLEAR TORIC

    MDR report key: 21549494 · Received March 7, 2025

    Report

    Report Number
    MW5167398
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 28, 2025
    Report Date
    March 4, 2025
    Manufacturer
    COOPERVISION INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE BEEN USING MONTHLY CONTACTS FROM COOPER. I NOTICED THAT IT CAN EASILY RIPPED WHILE I WAS WEARING IT. IT CAUSED EYE IRRITATION, PAIN AND NEED AN IMMEDIATE REMOVAL. OTHERWISE, NO ANALGESICS WERE NEEDED. I HAVE HAD THIS PROBLEM MULTIPLE TIMES AND HAVE ALSO REPORTED TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144201 PROCLEAR TORIC LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown