BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 10177072 · Received June 19, 2020

    Report

    Report Number
    3005675890-2020-00028
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 26, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F 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

    (B)(6). 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 WAS PERFORMED. PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE FAILURE MODE, PROBABLE CAUSE, RISK ASSESSMENT AND/OR LABELING REVIEW OF THIS INCIDENT, THERE WAS NO DEFICIENCY IN DESIGN OR MANUFACTURING OF THE PRODUCT IN QUESTION. NON CONFORMANCE WAS NOT IDENTIFIED, AND NO DEVICE FAILURE WAS IDENTIFIED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED MULTIPLE SYSTEM ERRORS AND SUCTION LOSS DURING LASER FIRING WHILE PERFORMING THE CATALYS PROCEDURE. THE PROCEDURE WAS COMPLETED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636675 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 LIQUID OPTICS INTERFACE SIZE 12, GEN2 LOT: UNKNOWN