BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4061721 · Received September 4, 2014

    Report

    Report Number
    2648035-2014-00452
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    April 30, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT DURING THE IMPLANTATION OF AN ZMB00 INTRAOCULAR LENS, THE SURGEON NOTED THAT HE HAD ''POPPED'' THE CAPSULAR BAG. HE CUT THE LENS IN HALF AND TOOK IT OUT AND DISCARDED IT. THE REPORT INDICATED THE EVENT WAS DUE TO ''USER ERROR'' AND THAT AN INCISION ENLARGEMENT WAS NOT REQUIRED TO REMOVE THE DEVICE. PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542376 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention