BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALMIC FEMTOSECOND LASER

    MDR report key: 11305407 · Received February 9, 2021

    Report

    Report Number
    3006695864-2021-07110
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 9, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K200056. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE REPLACED THE VACUUM CONTROL PRINTED CIRCUIT BOARD (PCB) AND FACE PLATE; SYSTEM VACUUM WAS CALIBRATED AND A FIELD SERVICE CHECKLIST WAS PERFORMED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR CATALYS SYSTEM (S/N (B)(4)) SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT SUCTION LOSS DURING LASER FIRING. ERROR 02-006 (POSSIBLE FLUID/SUCTION LOSS - PATIENT MOVEMENT DETECTED ERROR) WAS OBSERVED. THE PROCEDURE WAS COMPLETE SUCCESSFULLY AND WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201566 OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1