BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 8010031 · Received October 26, 2018

    Report

    Report Number
    3005675890-2018-00098
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 29, 2018
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (B)(4), AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MANUFACTURING SITE REPORTED THAT MANUFACTURING DATE IS AUGUST 2015 IT WAS REPORTED THAT PATIENT IS 20/20 AFTER IMPLANTING A 3 PIECES IOL. NO VISION AFFECTED. SURGEON IS SATISFIED WITH SYSTEM. SURGEON PERFORMED 12 CASES AFTER THE REPORTED EVENT WITH NO ISSUES. AFTER REVIEWING THE CASE, THE ISSUE WAS MORE RELATED TO THE USE OF THE SYSTEM AND TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(6). MANUFACTURING YEAR IS 2015. APPLICATION SUPPORT MANAGER WAS PRESENT AT THE TIME AND REPORTED THAT THE SUCTION RING WAS NOT WELL CENTERED AND ALSO THE PUPIL WAS NOT WELL CENTERED DURING THE OCT (OPTICAL COHERENCE TOPOGRAPHY). PATIENT WAS NOT COOPERATIVE AND SURGEON AGREED TO GO AHEAD AND NOT TO STOP TO DO MODIFICATIONS OR TO START OVER. 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 HAS BEEN REPORTED THAT PATIENT WAS HAVING CATARACT PROCEDURE WITH CATALYS SYSTEM. DURING DOCKING THERE WAS VACUUM LOSS DUE TO THE PATIENT MOVEMENT (IT WAS REPORTED PATIENT WAS NOT COOPERATIVE). AFTER RE-DOCKING, PROCEDURE WAS DONE. WHEN PATIENT WENT TO THE OPERATING ROOM AND WAS POSITIONED UNDER THE MICROSCOPE, THE EDGES OF THE CAPSULOTOMY WERE NOT CLEAR ENOUGH ON THE SCREEN. SURGEON WAS INSTRUCTED TO FOLLOW CCC (CONTINUOUS CURVILINEAR CAPSULORRHEXIS) TECHNIQUE WITH THE CAPSULOTOMY AND TO TAKE CARE. HOWEVER, WHEN SURGEON INJECTED THE VISION BLUE HE REPORTED THE CAPSULOTOMY WAS CLEAR TO SEE AND HE STARTED TO REMOVE IT WHEN HE NOTICED THE CUT WAS NOT COMPLETE. DOCTOR STARTED AGAIN TO MANAGE BUT UNFORTUNATELY HE GOT EXTENDED CAPSULOTOMY WITH CAPSULE RUPTURE. HE DID A VITRECTOMY FOR THE PATIENT AND IMPLANTED A 3 PIECES IOL. WHEN REVIEWING THE CATALYS REPORT IT WAS NOTICED THERE WAS AN INCOMPLETE CAPSULOTOMY AND THERE WAS TEAR IN THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849178 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention