BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 7096916 · Received December 7, 2017

    Report

    Report Number
    3008772169-2017-00566
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 19, 2018
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN DEVICE EVALUATED BY MFR, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER 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

    A PHYSICIAN REPORTED AN INCOMPLETE FLAP ON A PATIENT'S LEFT EYE DURING A REFRACTIVE PROCEDURE. DOCKING AND SUCTION STEPS WERE COMPLETED IN THE APPROPRIATE POSITION. THE LASER PEDAL WAS PRESSED. CUTTING WAS NOT COMPLETED ON AN AREA NEAR THE PUPIL CENTER DURING THE FLAP BED CUTTING. NO PROBLEM WAS EXPERIENCED IN SIDE CUTTING. FLAP THICKNESS WAS INCREASED FROM WHAT WAS PLANNED. PROCEDURE WAS ATTEMPTED A SECOND TIME. HOWEVER, THE CASE WAS POSTPONED FOR PHOTO REFRACTIVE KERATOMETRY (PRK) BECAUSE THE PATIENT'S FLAP COULD NOT BE REMOVED PROPERLY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878007 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other