BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 15710916 · Received November 1, 2022

    Report

    Report Number
    3012236936-2022-02677
    Event Type
    Injury
    Date Received
    November 1, 2022
    Report Date
    November 28, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H4 DEVICE MANUFACTURING DATE: IN THE INITIAL REPORT, THE DEVICE MANUFACTURING DATE WAS NOTED AS APR 22, 2015. THE CORRECT MANUFACTURING DATE IS 06/18/2015. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE ACCOUNT REPORTED A PATIENT HAD POSTERIOR TEAR/DROPPED NUCLEUS ON THE RIGHT (OD) EYE DURING CATARACT SURGERY AND REQUIRED AN UNPLANNED VITRECTOMY AND SUTURES. THE ACCOUNT MENTIONED THEY THINK THE BUBBLE PRODUCED BY THE LASER TO CREATE THE INCISION MAY HAVE CAUSED THE EVENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512503 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention LOI LOT #20198068.