BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNIFE

    MDR report key: 1514091 · Received October 21, 2009

    Report

    Report Number
    2523835-2009-00011
    Event Type
    Injury
    Date Received
    October 21, 2009
    Date of Event
    August 18, 2009
    Report Date
    August 19, 2009
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 10/21/2009.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE KNIFE WAS DULL AND HE PUSHED HARDER, THE KNIFE INADVERTENTLY PUNCTURED THE LENS. VITREOUS ENTERED THE ANTERIOR CHAMBER, AS A RESULT THE SURGEON DECIDED TO ABORT THE PROCEDURE. ADD'L FOLLOW-UP INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982865 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention