BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNIFE

    MDR report key: 2060973 · Received April 1, 2011

    Report

    Report Number
    2523835-2011-00024
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 3, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE RETURNED FOR EVALUATION AND ANALYSIS. VISUAL EVALUATION UNDER MAGNIFICATION SHOWED NO METAL PARTICULATES WERE PRESENT ON EITHER KNIFE. A LOT HISTORY SEARCH COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE ROOT CAUSE FOR THE METAL PARTICLES EXPERIENCED BY THE CUSTOMER IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT METAL PARTICLES WERE OBSERVED IN A PT'S EYE AFTER USE OF TWO KNIVES. THE PARTICLES REMAIN IN THE EYE. ADDITIONAL INFORMATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other