BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 11152832 · Received January 11, 2021

    Report

    Report Number
    3005675890-2021-07002
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 11, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    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) # K200056. JOHNSON & JOHNSON SURGICAL VISION¿S INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYS SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE JOHNSON & JOHNSON SURGICAL VISION, INC HAS ISSUED AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    VACUUM LOSS AFTER LASER FIRING WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE CATALYS LASER PROCEDURE ON (B)(6) 2020, VACUUM WAS LOST DURING THE LASER FIRING PORTION OF THE PROCEDURE. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42448 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1