BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCLEAR

    MDR report key: 3060467 · Received April 11, 2013

    Report

    Report Number
    9614392-2013-00016
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 14, 2013
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    K952152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE BY BOOTS OPTICIANS LIMITED OF A PATIENT WHO MAY OF CONTRACTED ACANTHAMOEBA KERATITIS. THE PATIENT MAY OF WORN PROCLEAR LENSES. ACANTHAMOEBA KERATITIS CAN LEAD TO PERMANENT VISION LOSS. THE REPORT IS UNCONFIRMED. NO LENSES WERE RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156904 PROCLEAR SOFT CONTACT LENS, DAILY WEAR LPM COOPERVISION MANUFACTURING, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other