BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 12317124 · Received August 13, 2021

    Report

    Report Number
    3006695864-2021-08221
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 18, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G3:(B)(6) 2021. FOR THE INITIAL REPORT, IT WAS INCORRECTLY REPORTED, THAT THE AWARE DATE WAS (B)(6) 2021. THE CORRECT DATE AWARE IS (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K113479. DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WAS PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT 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. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUCTION LOSS WHILE LASER FIRING. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218959 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1