BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS SYSTEM

    MDR report key: 21162003 · Received January 15, 2025

    Report

    Report Number
    3012236936-2025-000014
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Report Date
    April 18, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - DEVICE IDENTIFIER. NOT AVAILABLE AS DEVICE IS AN INTERNATIONAL PRODUCT WITH A SAME/SIMILAR MODEL FOR UNITED STATES MARKET. SEE NOTE FOR G4 BELOW ALL FOUR (4) EVENTS INVOLVED SYSTEM SERIAL NUMBER (B)(6). E1 SECTION - EVENTS HAPPENED AT THE SAME LOCATION THEREFORE, PROVIDING CONTACT INFO IN E1 E1 - PHONE NUMBER (B)(6). G4: 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) # K113479. FOUR (4) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS CORRECTION IS BEING SUBMITTED TO INCLUDE THE WORD "VMSR" IN THE EXEMPTION/VARIANCE NUMBER FIELD SINCE THE INITIAL REPORT WAS SUBMITTED BLANK.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 4 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
    1364368 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown