BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 3932206 · Received July 14, 2014

    Report

    Report Number
    2648035-2014-00342
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON SUSPECTS THE AMO TUBING CASSETTE PACK WAS THE CAUSE OF THE POSTERIOR CAPSULE RUPTURE. THE SUSPECTED TUBING PACK WAS NOT RETURNED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE THE LOT HISTORY AND TESTING COULD NOT BE CONDUCTED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED PRIOR TO STARTING A CATARACT PROCEDURE, THE SOUND OF IRRIGATION PERFORMANCE AND THE IRRIGATION FLOW VOLUME WAS EXCESSIVE, CONSEQUENTLY LEADING TO A POSTURE CAPSULE RUPTURE. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED OUT OF THE CAPSULE AND PROCEDURE WAS COMPLETED. THE SURGEON SUSPECTS THE CAUSE OF THE ADVERSE EVENT WAS RELATED TO THE AMO TUBING CASSETTE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409463 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC ABBOTT MEDICAL OPTICS OPO71

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNIT MODEL NGP680300, SERIAL NO. (B)(4)