BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 1619654 · Received February 22, 2010

    Report

    Report Number
    2020664-2010-00003
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K981116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): AN AMO FIELD SERVICE TECHNICIAN EVALUATED THE EQUIPMENT AT THE CUSTOMER LOCATION AND CONFIRMED THE ERROR. TESTING OF THE COMPONENTS REVEALED THAT THE VACUUM SENSOR HAD A DISCONTINUITY. IN ADDITION BALANCED SALT SOLUTION WAS FOUND IN THE VENTURI PUMP. THE VACUUM SENSOR WAS REPLACED AND THE PUMP WAS CLEANED. UPON COMPLETION OF THE SERVICE, THE SYSTEM WAS TESTED AND MET THE DEVICE SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT DURING A PHACOEMULSIFICATION PROCEDURE THE MACHINE STOPPED WITH AN ERROR WHICH WAS NOT ABLE TO BE CLEARED. THE DOCTOR DID NOT WANT TO WAIT FOR A BACK UP MACHINE TO BE PREPARED AND INSTEAD CONVERTED THE PROCEDURE TO A MANUAL EXTRACTION TO REMOVE THE REMAINING LENS FRAGMENTS. A CAPSULAR TEAR OCCURRED DURING THE MANUAL EXTRACTION, HOWEVER, THIS DID NOT RESULT IN ANY LOSS OF VITREOUS. THE IOL WAS IMPLANTED IN THE SULCUS AND THE WOUND WAS SUTURED CLOSED. THE PT'S OUTCOME IS EXPECTED TO BE GOOD; HOWEVER, A DELAY IN HEALING IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other