BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3810791 · Received March 21, 2014

    Report

    Report Number
    3008772169-2014-00028
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER CONDUCTED AN ON-SITE INVESTIGATION, SERVICE PART RETURNED, BUT NOT EVALUATED. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED ON BEHALF OF THE CUSTOMER UNINTENDED GANTRY MOVEMENT NOTICED DURING ONSITE SERVICING VISIT FOR ANOTHER SYSTEM. RPTR INDICATED THE ISOLATED MOVEMENT OCCURRED WHEN THE SYSTEM WAS TURNED OFF, BUT POWER WAS STILL AVAILABLE. THE RPTR RETURNED THE FOLLOWING WEEK TO ADDRESS THE GANTRY ISSUE DURING PREVENTATIVE MAINTENANCE. RPTR INDICATED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169639 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1