BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS SYSTEM

    MDR report key: 7564756 · Received June 4, 2018

    Report

    Report Number
    3005675890-2018-00034
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 9, 2018
    Report Date
    July 3, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: MANUFACTURING SITE PROVIDED MANUFACTURING DATE AS OCTOBER 2014.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST (FSS) CONFIRMED ALL VACUUM LEVELS WERE WITHIN SPECIFICATION ON ARRIVAL. FSS REPLACED THE VACUUM REGULATOR BOARD AND CALIBRATED VACUUM. MULTIPLE DAILY ALIGNMENT VERIFICATIONS WERE COMPLETED WITH A KNOWN GOOD LIQUID OPTICS INTERFACE (LOI). LOIS IN USE DURING THE CANCELLED CASES WERE TESTED AND COMPARED TO THE KNOWN GOOD LOI. THE LARGE LOIS WOULD NOT ACHIEVE OR HOLD SUCTION ON A SPHERE AS READILY AS THE CONTROL AND TYPICALLY REQUIRED ADDITIONAL DOWN FORCE ON THE SPHERE TO ACHIEVE THE SAME RESULT AS THE CONTROL LOI. MANUFACTURER DATE IS UNKNOWN AS IT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT DURING A PROCEDURE AND WHILE LASER WAS FIRING THE SYSTEM EXPERIENCED A SUCTION LOSS. CUSTOMER REPORTED HAVING TO CANCEL CASES DUE TO BEING UNABLE TO ACHIEVE PROPER SUCTION AT THE LIQUID OPTICS INTERFACE WHICH CAUSED A PATIENTS¿ EYE TO SHIFT. PATIENT WAS PARTIALLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407781 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 LIQUID OPTICS INTERFACE| LIQUID OPTICS INTERFACE