BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7887016 · Received September 18, 2018

    Report

    Report Number
    3005675890-2018-00075
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 23, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    A MANUFACTURER RECORD REVIEW RELATED TO THE DEVICE INCLUDING DEVICE HISTORY RECORD WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED THAT CHANGES THE FACTS AND/OR CONCLUSION, 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

    SURGEON REPORTED DURING CORTEX REMOVAL OF THE LEFT EYE VITREOUS WAS NOTED IN THE ANTERIOR CHAMBER AND A VITRECTOMY WAS REQUIRED. SURGEON REPORTED THAT THE CATALYST TREATMENT WAS PERFORMED WITHOUT INCIDENT. SURGEON HAD ALREADY INSERTED A PCB00 28.0 DIOPTER LENS AND IT HAD TO BE REMOVED A VITRECTOMY THEN WAS DONE AND THE LENS WAS REPLACED BY A NON-JOHNSON AND JOHNSON PRODUCT. PER FOLLOW-UP COMMUNICATION THE SURGEON REPORTED THAT THE PATIENT IS DOING FINE POST-OPERATIVELY. THIS REPORT IS FOR THE CATALYST SYSTEM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PCB00 LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727621 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PCB00, SN: (B)(6)