BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7480932 · Received May 2, 2018

    Report

    Report Number
    3005675890-2018-00023
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 3, 2018
    Report Date
    May 2, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE SPECIALIST CHECKED THE LASER USING THE FULL SYSTEM CHECKLIST AND EVERYTHING CHECKED TO SPECIFICATIONS. PERFORMED A DAILY ALIGNMENT VERIFICATIONS (DAV) AND A MOCK TREATMENT AND SYSTEM MET SPECIFICATIONS. COULD NOT FIND AN ISSUE WITH THE LASER. LOG FILES WERE COLLECTED AND SENT TO QUALITY FOR REVIEW. 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 LASER DIDN¿T CUT THE LENS COMPLETELY AND THERE WAS A TEAR IN THE BAG THAT REQUIRED A VITRECTOMY TO BE PERFORMED. INTRAOCULAR LENS WAS PLACE IN SULCUS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED BY JOHNSON & JOHNSON VISION APPLICATIONS SUPPORT MANAGER. HOWEVER, SURGEON STOPPED THE CONVERSATION AND SAID HE HAD NO TIME TO DISCUSS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322128 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention