BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 19996379 · Received August 15, 2024

    Report

    Report Number
    3012236936-2024-000212
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Report Date
    September 13, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE CATALYS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE CATALYS SYSTEM IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. (B)(6) SECTION H3: THE CATALYS WAS NOT EVALUATED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE INITIAL REPORT IT WAS REPORTED THAT THE SURGEON HAD SIX OUTAGES WITHIN A WEEK WHILE USING THE CATALYS LASER SYSTEM. HOWEVER DURING FURTHER REVIEW IT WAS DETERMINED THAT THERE WAS AN ERROR IN TRANSLATION FROM GERMAN TO ENGLISH AND IT WASN'T OUTAGES THAT WERE REPORTED BUT RATHER FAILURES WITH THE IRIS REGISTRATION. THEREFORE, THE EVENT IS NO LONGER CONSIDERED REPORTABLE PER OUR PROCEDURES AND NO FURTHER REPORTS WILL BE SUBMITTED UNDER REPORT NUMBER 3012236936-2024-0002122 H6. ADVERSE EVENT PROBLEM - DEVICE CODE: REMOVED: 4019 - UNEXPECTED SHUTDOWN; ADDED: 1559 - FAILURE TO SENSE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE COS 7 UPDATE TO THE SYSTEM, THE SURGEON HAD SIX OUTAGES WITHIN A WEEK WHILE USING THE CATALYS LASER SYSTEM. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894486 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose