BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3112071 · Received May 7, 2013

    Report

    Report Number
    3002037047-2013-00032
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ALCON - BELGIUM/ S.A. ALCON - COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A NEEDLE BROKE OFF WHILE IN A PATIENT'S EYE DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE BROKEN NEEDLE WAS REMOVED DURING THE SAME SURGICAL PROCEDURE WITHOUT HARM TO THE PATIENT. THIS IS THE SECOND OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197782 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ S.A. ALCON - COUVREUR N.V. CUSTOM PAK 354535

    Patients

    Seq Age Sex Outcome Treatment
    1 VISITEC IRRIGATION CYSTOTOMA 0.4MM