BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS LASER

    MDR report key: 16236071 · Received January 24, 2023

    Report

    Report Number
    3012236936-2023-00168
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    April 27, 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

    SERIAL NUMBERS OF THE DEVICES AND QUANTITY (B)(4), (X1). (B)(4), (X1). (B)(4), (X1). (B)(4), (X3). (B)(4), (X4). 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. THERE WERE 5 INVESTIGATIONS COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. A REVIEW OF THE 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

    ADDITIONAL INFORMATION: FIVE (5) 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 10 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
    1033490 CATALYS LASER OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown