BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 15351756 · Received September 2, 2022

    Report

    Report Number
    2028159-2022-01291
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    April 4, 2022
    Report Date
    September 2, 2022
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO CONFIRM OR REPLICATE THE REPORTED EVENT. AS A PREVENTATIVE MEASURE, THE COMPANY SERVICE REPRESENTATIVE OPTIMIZED SYSTEM FOR FLAP BY ADJUSTING VACUUM PRESSURE AND CHECKING SURGICAL APPLANATION FORCE. THE COMPANY SERVICE REPRESENTATIVE OPTIMIZED LASER ENGINE, INCLUDING STRETCH/COMPRESSOR TO ROUND BEAM, SEEDING AND HR MIRRORS, AND DUMP TIME (FLAP + CATARACT). THE COMPANY SERVICE REPRESENTATIVE ALIGNED BEAM THROUGH BEAM CONDITIONER, ALIGNED ENERGY POCKET CELL, BEAM STEERING AND COARSE DELIVERY ALIGNMENT. THE COMPANY SERVICE REPRESENTATIVE CALIBRATED CATARACT AND FLAP ENERGY POLYNOMIALS AS WELL AS DIAMETER AND FLAP DEPTH. THE COMPANY SERVICE REPRESENTATIVE ALSO ADJUSTED VIDEO MICROSCOPE OFFSETS. THE COMPANY SERVICE REPRESENTATIVE CLEANED AIR FILTERS, ADDED COOLANT, AND CLEANED OBJECTIVE LENS. THE COMPANY SERVICE REPRESENTATIVE ALSO CHECKED FIGURE OF MERIT FOR FLAP. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO INFORMATION WAS PROVIDED TO CONCLUSIVELY INDICATE NONCONFORMANCE OF THE SYSTEM CONTRIBUTED TO THE REPORTED EVENT. THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. THUS, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. ALCON LENSX (SITE # (B)(4) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE # (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A SURGEON REPORTED AN INCOMPLETE FLAP DURING FLAP CREATION ON THE PATIENT'S LEFT EYE. THERE WAS NO PATIENT HARM REPORTED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414554 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 Male