BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVS ONE STEP CLEANING AND DISINFECTANT SOLUTION

    MDR report key: 520833 · Received April 8, 2004

    Report

    Report Number
    2438562-2004-00003
    Event Type
    Other
    Date Received
    April 8, 2004
    Date of Event
    October 1, 2003
    Report Date
    November 13, 2003
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RED AND BLOOD SHOT EYE, CUSTOMER REPORTS NOT HAVING NOTICED WARNING THAT LENSES/PRODUCT CAN NOT BE PLACED DIRECTLY IN THE EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVS ONE STEP CLEANING AND DISINFECTANT SOLUTION CLEANING AND DISINFECTING LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD. * 56361

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other