BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM

    MDR report key: 6152204 · Received December 7, 2016

    Report

    Report Number
    9615939-2016-01002
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    January 1, 2014
    Report Date
    November 30, 2016
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED COPY OF LETTER FROM FDA TO RITE AID REGARDING THIS EVENT: MW#:5038176. 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

    ON (B)(6) 2014, THE PATIENT REPORTED SYMPTOMS OF TWO DAYS OF HAZY, BLUR, STINGING, SEARING, AND BURNING EYE PAIN AND REACTION IN BOTH EYES (OU). THE PATIENT ALLEGES LOSS OF VISION, LIGHT SENSITIVITY, AND IRRITATION. THE PATIENT WAS NOT PRESCRIBED ANY MEDICATIONS. THE OUTCOMES ARE TEMPORARY HARM/INJURY AND THE PATIENT'S SYMPTOMS ABATED. IN THE ABSENCE OF MEDICAL INFORMATION, THIS EVENT IS BEING REPORTED IN ABUNDANCE OF CAUTION BASED ON THE ALLEGED VISION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802506 ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other