BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 LE LASER

    MDR report key: 1885093 · Received October 20, 2010

    Report

    Report Number
    2028159-2010-01990
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REQUEST IS ON HOLD. 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

    THE CUSTOMER REPORTED THE AIMING BEAM IS DISPLACED AND IT IS MAKING A MARK ON THE IOL. ADDITIONAL INFORMATION WAS REQUESTED ON THE EVENT AND PATIENT STATUS. THE PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3000 LE LASER LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER 3000LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI