BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6112975 · Received November 18, 2016

    Report

    Report Number
    3008772169-2016-00789
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 1, 2016
    Report Date
    February 16, 2017
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE VISITED THE SITE AND FOUND THAT THE VIDEO MICROSCOPE X AND Y SCALES WERE NOT PROPERLY CALIBRATED. THE COMPANY REPRESENTATIVE PERFORMED A CALIBRATION AND VERIFIED THE VIDEO MICROSCOPE OVERLAYS. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE VIDEO MICROSCOPE X AND Y SCALES BEING OUT OF CALIBRATION. HOW AND WHEN THEY BECAME OUT OF CALIBRATION CANNOT BE DETERMINED CONCLUSIVELY AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE MFR INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    UPON FOLLOW UP, THE DOCTOR REPORTED IT WAS ANTERIOR AS HE THOUGHT. PATIENT IS REPORTED TO BE DOING FINE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED AND ARCUATE THAT WAS PERFORMED CENTRALLY IN THE PUPIL MARGIN DURING A LASER ASSISTED CATARACT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764091 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other