BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 12016885 · Received June 17, 2021

    Report

    Report Number
    2028159-2021-00647
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 27, 2021
    Report Date
    October 7, 2021
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO CONFIRM OR REPLICATE ANY SYSTEM NONCONFORMITY WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE PERFORMED EQUIPMENT VERIFICATION AND PERFORMED TEST PROCEDURES WITH NO PROBLEMS FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE COULD NOT 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 CUSTOMER REPORTED LASER WAS NOT EFFECTIVELY CUTTING DURING FLAP CREATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914127 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1