BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYS

    MDR report key: 3881418 · Received April 9, 2014

    Report

    Report Number
    3008772169-2014-00035
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ALCON LENSX LASER INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 CLINICAL DIRECTOR REPORTED WHILE FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR SERVICING FOR OTHER EQUIPMENT, HE PROACTIVELY PERFORMED CHECK OUT THE LASER PRIOR TO SOFTWARE UPGRADE. REPORTER INDICATED FSE NOTED THE UNINTENDED GANTRY MOVEMENT WHEN HE KEYED OFF THE SYSTEM. REPORTER RELAYED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214069 LENSX LASER SYS OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX LASER INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA