BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 19091502 · Received April 11, 2024

    Report

    Report Number
    3012236936-2024-01110
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 20, 2024
    Report Date
    May 20, 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
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. 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. DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED GENERAL CHECKLIST, CLEANED AND OPTIMIZED OPTICS AND VERIFIED WITH DAILY ALIGNMENT VERIFICATION (DAV) AND MOCK TREATMENT. SYSTEM PERFORMING TO SPECIFICATION. ALSO, APPLICATION SUPPORT MANAGER (ASM) PROVIDED PHONE SUPPORT AND ADVISED SURGEON OF THE IMPORTANCE OF CURVILINEAR CAPSULORHEXIS (CCC) TECHNIQUE, PER TRAINING MESSAGE TO ENSURE DECREASED RISK OF RADIAL TEAR. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: H4 DEVICE MANUFACTURE DATE: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 01/28/2014, HOWEVER THE CORRECT DATE IS 05/20/2013. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE PATIENT EXPERIENCED A RADIAL TEAR IN THE CAPSULAR BAG. THEY DID NOT NEED VITRECTOMY BUT THE PLAN HAD TO BE CHANGED FROM USING A TORIC INTRAOCULAR LENS (IOL) TO A SULCUS IOL. NO PATIENT IDENTIFIER INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581079 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown