BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 19392483 · Received May 24, 2024

    Report

    Report Number
    3012236936-2024-000150
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 24, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: INFORMATION REQUESTED AND IT WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LASER SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LASER SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION H3: DEVICE EVALUATION, THE CATALYS SYSTEM WAS NOT RETURNED FOR EVALUATION. AN APPLICATION SUPPORT MANAGER WAS ONSITE FOR SURGERY SUPPORT. ASM PROVIDED SURGERY SUPPORT FOR 6 CASES INCLUDING CAPSULOTOMY/ FRAGMENTATION/ ARCUATE INCISIONS. PRIOR TO THE CASES, ASM REVIEWED DOCKING UTILIZING THE LIQUID OPTICS INTERFACE, ALSO UTILIZED CATALYS SIMULATOR TO PRACTICE VISUALIZE/CUSTOMIZE AND INTEGRAL GUIDANCE. ASM REVIEWED TEMPLATES FOR CASE, SURGEON UTILIZED CAP/FRAG. ALL QUESTIONS WERE ANSWERED. SYSTEM WAS PERFORMING TO SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS DID NOT DILATE WELL, AND SURGEON DECIDED TO SUPPRESS CAPSULOTOMY. APPLICATION SUPPORT MANAGER INFORMED THE SURGEON TO CONSIDER SUPPRESSING FRAGMENTATION AS WELL. THE SURGEON DID NOT WANT TO SUPPRESS FRAGMENTATION. WHILE TRYING TO REMOVE THE NUCLEUS, THE SURGEON HAD TO PERFORM A VITRECTOMY. AFTER SPEAKING WITH SURGEON, HE COMMENTED THAT IT WAS A COMPLICATED CASE AND DOESN¿T BELIEVE THIS WAS DUE TO THE CATALYS LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623607 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention