BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS-I

    MDR report key: 11378104 · Received February 25, 2021

    Report

    Report Number
    3006695864-2021-07252
    Event Type
    Injury
    Date Received
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE : (B)(6). DEVICE EVALUATION: THE CATALYS MACHINE LASER WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN JJSV FIELD SERVICE SPECIALIST.(FSS). ENGINEER PERFORMED FULL SYSTEM CHECKLIST. THE SYSTEM HAS BEEN FOUND IN FULL J&J SPECIFICATIONS. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET JJSV SPECIFICATIONS. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THERE WERE NO ISSUES OR NONCONFORMANCE DURING MANUFACTURING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A CATALYS LASER TREATMENT, A POSTERIOR CAPSULE RUPTURED ON THE OPERATIVE EYE REQUIRING A VITRECTOMY PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274460 CATALYS-I OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention