BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5964414 · Received September 20, 2016

    Report

    Report Number
    3008772169-2016-00618
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    July 28, 2016
    Report Date
    November 26, 2016
    Manufacturer
    ALCON LENSX, 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
    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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    NO TECHNICAL SERVICES WERE REQUESTED OR PERFORMED ON THE SYSTEM DUE TO THE REPORTED EVENT. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DETERMINED CONCLUSIVELY. PUPILLARY RESPONSE IS THE PHYSIOLOGICAL RESPONSE OF THE PUPIL VARYING IN SIZE. POTENTIAL CONTRIBUTOR FACTORS COULD INCLUDE LIGHT STIMULANT, MEDICATIONS, AND/OR PATIENT MOOD. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPRESENTATIVE REPORTED DURING LASER ASSISTED CATARACT PROCEDURE SMALL PUPIL DILATION WAS OBSERVED. REPORTER INDICATED THE CONTROL POINTS FOR THE CAPSULE TREATMENT WERE REDUCED. AS CAPSULE TREATMENT BEGAN THE PUPIL SHRANK RAPIDLY TO A BEST ESTIMATE OF LESS THAN 4.0 DIAMETERS. THE RAPID PUPIL REDUCTION WAS SPECULATED BY THE SURGEON TO BE POSSIBLY FROM SLIGHT REDUCTION BETWEEN SETTING CONTROL POINTS AND FIRING, AND CAPSULE TREATMENT POSSIBLY TOUCHED PUPIL EDGE CAUSING THE MORE RAPID REDUCTION OF PUPIL SIZE. REPORTER ALSO INDICATED THAT SEVERAL LASER ROTATIONS OBSERVED ON IRIS SURFACE BEFORE PEDAL COULD BE RELEASED. AT RELEASE OF PEDAL, THE SYSTEM FROZE AND DISPLAYED AN ERROR MESSAGE, AND BECAME NON-RESPONSIVE. SUCTION WAS RELEASED AND LASER TREATMENT PORTION WAS ABORTED. THE CATARACT PROCEDURE WAS CONVERTED TO CONVENTIONAL TREATMENT METHOD, DILATION RETURNED TO SATISFACTORY SIZE FOR PROCEDURE AND SUCCESSFULLY COMPLETED. LIGHT TRACES OF CAPSULOTOMY PATTERN WERE OBSERVED ON THE IRIS, BUT NO ANTICIPATED COMPLICATION POST OPERATIVE. THE LASER WAS REBOOTED AND STANDARD CHECKS/CALIBRATIONS PERFORMED WITH ALL CLEARED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616865 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other