BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2043239 · Received February 25, 2011

    Report

    Report Number
    2523835-2011-00016
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE NOT BEEN RECEIVED FOR EVAL. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO METAL PARTICLES WERE FOUND DURING DHR REVIEW AND THE PRODUCT WAS RELEASE ACCORDING TO COMPANY ACCEPTANCE CRITERIA. ROOT CAUSE IS NOT DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT METAL PARTICLES WERE SEEN IN A PT'S EYE AFTER MAKING THE CATARACT INCISION WITH A METAL KNIFE. ADDITIONAL 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 8065992445 827066M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK