BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS LASER

    MDR report key: 16827084 · Received April 27, 2023

    Report

    Report Number
    3012236936-2023-00955
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Report Date
    July 28, 2023
    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

    CORRECTION: IN THE INITIAL REPORT THE FOLLOWING INFORMATION WAS INADVERTENTLY NOT INCLUDED. FIELD SERVICE ANALYST CHECKED THE SYSTEM. ELECTRICAL AND MECHANICAL PROBLEM WAS IDENTIFIED. PARTS WERE REPLACED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE RISKS AND MITIGATION'S ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SERIAL NUMBERS OF THE DEVICES AND QUANTITY: (B)(6), (X1), (B)(6), (X1). 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. THE 2 INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THE SYSTEMS AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. 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 EVENT WAS 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
    1156943 CATALYS LASER OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown