BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2072407 · Received April 8, 2011

    Report

    Report Number
    1644019-2011-00014
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    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

    BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE FOREIGN MATERIAL EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/08/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT OVER A PERIOD OF A COUPLE OF MONTHS, 19 PATIENTS HAVE BEEN FOUND TO HAVE BLUE FIBERS IN THEIR EYES POSTOPERATIVELY. THEY DID NOT NEED INTERVENTION TO REMOVE THE FIBERS AND NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK