BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS SYSTEM

    MDR report key: 13389707 · Received January 28, 2022

    Report

    Report Number
    3012236936-2022-00255
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Report Date
    January 28, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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) # K121091. ALL TWO (2) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309946 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown