BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIDEK

    MDR report key: 376078 · Received February 5, 2002

    Report

    Report Number
    2936921-2002-00002
    Event Type
    Other
    Date Received
    February 5, 2002
    Date of Event
    November 28, 2001
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NIDEK LEARNED OF THE FOLLOWING EVENT: DURING CATARACT SURGERY, WHILE USING PHACO-HANDPIECE, SMALL PIECES OF METAL OBSERVED FLOATING IN FRONT OF IRIS. THE SURGEON IRRIGATED PIECES OUT OF WOUND AND EYE. PHACO HANDPIECE IMMEDIATELY REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    NIDEK LEARNED OF THE FOLLOWING EVENT FROM CDRH MW 1023580. DURING CATARACT SURGERY, WHILE USING PHACO-HANDPIECE, SMALL PIECES OF METAL OBSERVED FLOATING IN FRONT OF IRIS. THE SURGEON IRRIGATED PIECES OUT OF WOUND AND EYE. PHACO HANDPIECE IMMEDIATELY REMOVED FROM SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK NIDEK PHACOEMULSIFICATION SYSTEM HQC NIDEK CO. LTD. CV-12000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention