BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVS ONE STEP CLEANING AND DISINFECTING SOLUTION

    MDR report key: 601267 · Received July 2, 2004

    Report

    Report Number
    2438562-2004-00008
    Event Type
    Other
    Date Received
    July 2, 2004
    Date of Event
    November 9, 2003
    Report Date
    March 16, 2004
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD.
    Product Code
    LPN
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RINSED THEIR LENSES WITH THE SOLUTION. THEY EXPERIENCED IRRITATION OF THE EYE AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVS ONE STEP CLEANING AND DISINFECTING SOLUTION CLEANING AND DISINFECTING LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD. * 56875

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other