BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 2030935 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00200
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MDM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE SAMPLE WAS RELEASED ACCORDING TO MANUFACTURE ACCEPTANCE CRITERIA. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SCISSOR TIP BROKE INSIDE A PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE WAS NO HARM OR INJURY TO THE PATIENT. ALSO, THE INSTRUMENT USED DURING THE EVENT WAS APPROXIMATELY FIVE YEARS OLD, BUT HAD NOT BEEN USED OFTEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM MDM ALCON - IRVINE TECHNOLOGY CENTER NA F55808

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR