BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM

    MDR report key: 5998571 · Received October 4, 2016

    Report

    Report Number
    9615939-2016-01000
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    July 29, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CANNOT BE PERFORMED. NO LENSES WERE RETURNED FOR EVALUATION AND LOT NUMBER IS UNKNOWN. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SWELLING AND BLURRED VISION AFTER USE OF ONE STEP PEROXIDE LENS CARE SYSTEM, WHICH RESULTED IN A PERMANENT REDUCTION OF VISUAL ACUITY. MEDICAL ATTENTION WAS SOUGHT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. THIS EVENT IS BEING REPORTED OUT OF ABUNDANCE OF CAUTION BECAUSE IT IS UNKNOWN IF THE BLURRY VISION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650324 ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD 127592

    Patients

    Seq Age Sex Outcome Treatment
    1 Other