BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN

    MDR report key: 2161728 · Received July 8, 2011

    Report

    Report Number
    2020664-2011-00036
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS (AMO)
    Product Code
    HQC
    PMA / PMN Number
    K003638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION AND ANALYSIS OF THE UNIT WAS COMPLETED BY A FIELD SVC ENGINEER. A PREVENTATIVE MAINTENANCE WAS PERFORMED. ENGINEER CHECKED ALL CONNECTIONS AND ALL PCB'S (PRINTED CIRCUIT BOARDS) WERE SEATED CORRECTLY. THE UNIT PASSED ALL FUNCTIONAL CHECKOUTS AND MEETS AMO SPECIFICATIONS. INFO AND DISPOSITION OF TUBING NOT AVAILABLE AT THIS TIME. IF ADDITIONAL INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CATARACT PROCEDURE, THERE WAS LOW VACUUM AND ALSO STAFF NOTICED A LEAK ON THE TUBING. DUE TO BROKEN CAPSULE, AN ANTERIOR VITRECTOMY WAS PERFORMED. CUSTOMER WAS NOT SURE IF THIS WAS DUE TO THE LOW VACUUM ISSUE. IOL WAS PLACED IN THE SULCUS AND PT DID NOT REQUIRE SUTURES. THE CLINIC INDICATED COMPLETE PT RECOVERY IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN HQC ABBOTT MEDICAL OPTICS (AMO) SOV680300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention