BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 12620390 · Received October 12, 2021

    Report

    Report Number
    2020664-2021-07675
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 12, 2021
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER 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. FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND CHECKED THE LASER. HE FOUND THAT THE FLUID RESERVOIR WAS THE CAUSE FOR LOW PATIENT VACUUM. REPLACED IT AND PROACTIVELY REPLACED THE VACUUM CONTROL PRINTED CIRCUIT BOARD. HE PERFORMED CALIBRATIONS AND VERIFIED SYSTEM MET JNJ VISION SPECIFICATIONS. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY HAD SUCTION LOSS DURING THE PROCEDURE. THEY AND DETERMINED THAT THE LOIS MAY BE BAD; BUT WOULD LIKE TO HAVE THE LASER CHECKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515730 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1