BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 11841348 · Received May 18, 2021

    Report

    Report Number
    3006695864-2021-07699
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 18, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K200056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WEIGHT AND ETHNICITY: NOT AVAILABLE/NOT PROVIDED. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR CATALYS-U LASER 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. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. (B)(6) SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO (B)(6) SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED SUCTION LOSS OCCURRED DURING LASER FIRE AT 2.4 SECONDS AND IT ABORTED. THE SURGEON SUCCESSFULLY COMPLETED THE PROCEDURE MANUALLY IN THE MAIN OPERATING ROOM (OR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738293 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 LIQUID OPTICS INTERFACE.