BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3971817 · Received July 31, 2014

    Report

    Report Number
    2648035-2014-00380
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT DURING A CATARACT EXTRACTION SURGERY, THE CATARACT WAS REMOVED WITHOUT DIFFICULTY. BEFORE IMPLANTATION OF THE INTRAOCULAR LENS WAS COMPLETE, THE SURGEON NOTED CHOROIDAL EFFUSION AND THE LENS WAS NOT STABLE IN THE BAG. THE INCISION WAS ENLARGED AND THE INTRAOCULAR LENS WAS REMOVED AND DISCARDED AT THE SURGERY CENTER. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446591 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention