BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESH DAY MULTIFOCAL

    MDR report key: 5380499 · Received January 13, 2016

    Report

    Report Number
    MW5059396
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 13, 2016
    Manufacturer
    SAULFON
    Product Code
    MFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT NAME: VISION SOURCE FRESH DAY MULTIFOCAL CONTACT LENSES MANUFACTURED BY SAUFLON PHARMACEUTICAL'S LTD, IMPORTED BY: (B)(4) CATALOG #C29MD56IQZR1, LOT #U0019706 BC 8.6 DIA 14.1 PWR -2.25 HIGH ADD PRODUCT QUALITY PROBLEM. SEVERAL DID NOT APPEAR TO BE THE CORRECT PRESCRIPTION AND DID NOT PROPERLY CORRECT MY VISION. HAD TO DISCARD AND TRY ANOTHER LENS. I HAVE OCCASIONALLY COME ACROSS A LENS THAT DIDN'T FEEL RIGHT, BUT 5 IN A BOX PROBABLY A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24318 FRESH DAY MULTIFOCAL FRESH DAY MULTIFOCAL MFK SAULFON -2.25 HIGH ADD U00199706

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR