BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7776560 · Received August 13, 2018

    Report

    Report Number
    3005675890-2018-00066
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    THE LASER LABELING CONTAINS INFORMATION UNDER PRECAUTIONS REGARDING CATARACTS GREATER THAN GRADE 4 AS FOLLOWS: THE CATALYS® SYSTEM HAS NOT BEEN ADEQUATELY EVALUATED IN PATIENTS WITH A CATARACT GREATER THAN GRADE 4. INITIAL REPORTER'S PHONE NUMBER: (B)(\6). 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. 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 DURING CATALYS LASER TREATMENT WITH THE DEGREE OF NUCLEAR HARDENING EQUIVALENT TO FOUR (IV), AIR BUBBLES GENERATED BY IRRADIATION WERE CONCENTRATED ON A PART OF THE CAPSULE. THE ACCOUNT INDICATED THAT THERE WAS NUCLEUS DISLOCATION AND DAMAGE OF THE ANTERIOR CAPSULE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACK-UP LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617580 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other