BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLINNEUM SYSTEM

    MDR report key: 2973809 · Received July 26, 2007

    Report

    Report Number
    2973809
    Event Type
    Injury
    Date Received
    July 26, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 12, 2007
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT EYE CATARACT SURGERY. AFTER PHACOEMULSIFICATION COMPLETED WITHOUT INCIDENT, IRRIGATION AND ASPIRATION PORTION OF THE PROCEDURE WAS ATTEMPTED. AT THE BEGINNING OF IRRIGATION/ASPIRATION, THERE WAS MINIMAL VACUUM PRESENT AND ERROR WAS GIVEN MULTIPLE TIMES STATING, "LOW AIR PRESSURE." THE VALVE WAS APPARENTLY SET AT 60 AND INCREASED TO 110. INSTRUMENT WAS RE-PRIMED. PROCEEDED WITH PROCEDURE. AS THE VERY LAST PIECE OF CORTEX WAS ABOUT TO BE ASPIRATED THERE WAS A SUDDEN SURGE IN VACUUM RESULTING IN LOSS OF BOTH ANTERIOR AND POSTERIOR CAPSULES AND SOME VITREOUS. PT LEFT APHAKIC AFTER TRYING TO PLACE AN ACIOL. PT'S ULTIMATE OUTCOME UNK AT THIS TIME. RISK OF RETINAL DETACHMENT. IF RETINAL DETACHMENT DOES NOT OCCUR, MAY BE ABLE TO COMPLETE THE CATARACT SURGERY IN A FEW WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLINNEUM SYSTEM PHACO UNIT HQC BAUSCH AND LOMB CX6000, COM01892

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R