BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 7534898 · Received May 22, 2018

    Report

    Report Number
    3005675890-2018-00029
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 23, 2018
    Report Date
    June 22, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INCORRECT. MANUFACTURING SITE PROVIDED ONLY THE YEAR AS 2013.

    Additional Manufacturer Narrative · 1

    JOHNSON & JOHNSON SURGICAL VISION'S INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT 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. 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 HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE LASER WAS FIRING THE SYSTEM EXPERIENCED A SUCTION LOSS. THE WAS NO PATIENT INJURY REPORTED AND NO NEED FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376347 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1