BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3162033 · Received June 6, 2013

    Report

    Report Number
    3008772169-2013-00037
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 COMPANY REPRESENTATIVE ON BEHALF OF THE CUSTOMER REPORTED GANTRY IS MOVING DOWN WHEN POWER TO THE SYSTEM IS SHUT OFF. NO PATIENT INVOLVEMENT OR INJURY, NO CANCELLED SURGERIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251557 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1