BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11973764 · Received June 10, 2021

    Report

    Report Number
    3006695864-2021-07884
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 10, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K200056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: WEIGHT AND ETHNICITY: UNKNOWN/NOT PROVIDED. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CATALYS SYSTEM, SERIAL NUMBER (B)(4), SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    SURGEON A PERFORMED A CATALYSE PRECISION LASER SYSTEM PROCEDURE AND SUBSEQUENTLY HAD TO PERFORM AN UNPLANNED VITRECTOMY. SURGEON STATED THAT SHE WAS UNSURE HOW IT HAPPENED, BUT BELIEVED IT WAS NOT DUE TO THE CATALYSE LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869094 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention