BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS LASER

    MDR report key: 18576920 · Received January 24, 2024

    Report

    Report Number
    3012236936-2024-00190
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Report Date
    April 23, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: NINE (9) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE MODEL THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. DEVICE HISTORY RECORD (DHR) COULD NOT BE DONE AS THE SERIAL NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    H10 SERIAL NUMBERS OF THE DEVICES AND QUANTITY: (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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 13 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478343 CATALYS LASER OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown