BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO WHITESTAR

    MDR report key: 1062387 · Received June 6, 2008

    Report

    Report Number
    1062387
    Event Type
    Injury
    Date Received
    June 6, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    IN THE COURSE OF A ROUTINE CATARACT EXTRACTION, AFTER THE DOCTOR HAD INSERTED THE PHACOEMULSIFICATION TIP, APPLIED POWER, IRRIGATION AND ASPIRATION PER ROUTINE PRACTICE, AN IMMEDIATE CORNEAL BURN WAS NOTED. THERE WAS NO WARNING ALARM OR MESSAGE ON THE PHACO MACHINE TO INDICATE AN ERROR HAD OCCURRED. THE TIP WAS REMOVED, THE HANDPIECE WAS REPLACED WITH ANOTHER, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENCE.

    Description of Event or Problem · 1

    IN THE COURSE OF A ROUTINE CATARACT EXTRACTION, AFTER THE DOCTOR HAD INSERTED THE PHACOEMULSIFICATION TIP, APPLIED POWER, IRRIGATION AND ASPIRATION PER ROUTINE PRACTICE, AN IMMEDIATE CORNEAL BURN WAS NOTED. THERE WAS NO WARNING ALARM OR MESSAGE ON THE PHACO MACHINE TO INDICATE AN ERROR HAD OCCURRED. THE TIP WAS REMOVED, THE HANDPIECE WAS REPLACED WITH ANOTHER, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO WHITESTAR PHACOEMULSIFICATION MACHINE HQC ADVANCED MEDICAL OPTICS, INC. NGP680300 *
    2 * HANDPIECE, PHACOEMULSIFICATION HQE ADVANCED MEDICAL OPTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R