BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 23576614 · Received November 17, 2025

    Report

    Report Number
    3012236936-2025-000304
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 6, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPON ADDITIONAL INFORMATION RECEIVED, THE DEVICE CODE DC- SYSTEM ERROR DURING PROCEDURE IS NO LONGER APPLICABLE AND THE CODE IS UPDATED TO DC-SYSTEM ERROR NOT DURING PROCEDURE. THE LASER WAS NOT FIRING WHEN THE SYSTEM ERROR OCCURRED. NO PATIENT INJURY. THEY WERE ABLE TO COMPLETE THE CASE WITH MANUAL CATARACT EXTRACTION. THIS CASE IS NO LONGER REPORTABLE. THEREFORE, THIS FOLLOW-UP #1 IS BEING SUBMITTED TO PROVIDE THE UPDATED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MEDWATCH REPORT NUMBER 3012236936-2025-0003047.

    Additional Manufacturer Narrative · 0

    . SECTION H3: OUR FIELD SERVICE ENGINEER (FSE) WAS ONSITE FOR A SYSTEM CHECK. FSE WENT IN AND WAS UNABLE TO REPRODUCE ERROR. ONCE COMPLETING MOCK TREATMENT, SYSTEM ERROR. FSE REPLACED ZL ASSEMBLY, COMPLETED ALIGNMENT, FULL SYSTEM CHECKOUT, OCT LUT, AND DAV. WHEN SETTING UP MOCK TREATMENT, THE ZL ERROR POPPED UP AGAIN. FUTURE CASES WERE CANCELED. FSE WENT BACK IN AND REPLACED PI INTERFACE PRINTED CIRCUIT BOARD PCB. TESTED SYSTEM, COMPLETED DAV AND SETUP MOCK TREATMENTS OVER TEN TIMES WITH SPHERE AND SIMULATION EYE TO CONFIRM ERROR DID NOT OCCUR. COMPLETED A FULL MOCK TREATMENT FOR LEFT AND RIGHT EYE BEFORE RETURNING SYSTEM. SYSTEM IS WORKING ACCORDING TO SPECIFICATIONS. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A ZL IN POSITION ERROR ON THEIR CATALYS SYSTEM DURING A PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235078 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown