BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CATALYS SYSTEM

    MDR report key: 9240659 · Received October 25, 2019

    Report

    Report Number
    3005675890-2019-00091
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    October 28, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    UDI-DI
    05050474609792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS INITIALLY REPORTED THAT 2 OUT OF 3 INVESTIGATIONS WERE COMPLETED DURING THE PERIOD HOWEVER, ONLY ONE INVESTIGATION WAS COMPLETED. ADDITIONAL INFORMATION TWO INVESTIGATIONS WERE COMPLETED DURING THIS PERIOD. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THERE WERE NO ISSUES FOUND WITH THE SYSTEM. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F AND G. 4 DATE ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION SERIAL NUMBERS OF DEVICES: (B)(4). PMA/510K: 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. THE CATALYS SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE JOHNSON & JOHNSON SURGICAL VISION, INC HAS ISSUED AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. INVESTIGATION WERE COMPLETED FOR 2 OUT 3 OF THE REPORTED EVENTS. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THERE WERE NO ISSUES FOUND WITH THE SYSTEM. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS WHILE THE CATALYS LASER WAS FIRING. THERE WERE NO MEDICAL EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031694 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1