BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 19345598 · Received May 17, 2024

    Report

    Report Number
    3012236936-2024-000144
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 17, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SALES REP, VIA FACETIME, REVIEWED THE TREATMENT RECORD WITH THE LASER TECH. THE POSTERIOR UNCUT SECTION WAS SET AT 20% (WHICH IS STANDARD) AND THE ARC LENGTH WAS 37 DEGREES. THE TREATMENT IMAGE SHOWED THE CORNEA OVERLAYS WERE PROPERLY ALIGNED WITH THE OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGE. THE LASER TECH SAID THE CASE WENT NORMALLY AND THERE WAS NO NOTICEABLE PATIENT MOVEMENT. THE CUSTOMER PERFORMED A DAILY ALIGNMENT VERIFICATION (DAV) FOLLOWING THIS CASE AND ALIGNMENT LOOKED GOOD. SECTION H3: A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE 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

    IT WAS REPORTED THAT DOCTOR HAD A FULL THICKNESS ARCUATE INCISION USING THE CATALYS SYSTEM AND REQUIRED 2 SUTURES TO CLOSE THE INCISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642508 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention