BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7928940 · Received October 2, 2018

    Report

    Report Number
    3005675890-2018-00083
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    July 31, 2018
    Report Date
    November 2, 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

    MANUFACTURING YEAR 2014 A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. A REVIEW OF THE SYSTEM PATIENT FILE SHOWED NOTHING UNUSUAL SYSTEM WISE ABOUT THIS TREATMENT THAT WOULD POINT TO A CAPSULE RUPTURE AS BEING CAUSED BY CATALYS. THE OPTICAL COHERENCE TOMOGRAPHY FITS WERE GOOD, BUT THERE WAS SOME PATIENT MOVEMENT. HOWEVER, THE USER DID ADJUST THE PUPIL, LIMBUS, AND CYCLOTORSION ANGLE, SO THIS SUGGESTS THE USER NOTICED AND ADAPTED. THE FIT ON THE ANTERIOR CAPSULE WAS ACCURATE AND NOT ADJUSTED. OTHERWISE, THE TREATMENT LOOKS TYPICAL DURING THE CAPSULOTOMY. CAPSULOTOMY SETTINGS WERE ALSO NOMINAL. THERE WERE NO SIGNS OF SYSTEM ERROR. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A POSTERIOR CAPSULE BREAK. DURING FOLLOW UP THE SURGEON REPORTED THAT THE SUPERIOR PORTION OF THE CATARACT SHIFTED POSTERIORLY AND VITREOUS PROLAPSED FORWARD. A VITRECTOMY WAS PERFORMED. PATIENT CAME A WEEK AFTER THAT AND REPORTED STILL HAVING ISSUES WITH THE EYE (LEFT). THE LOCATION CONTACT REPORTED THAT PATIENT HAD SEVERAL VITRECTOMIES HOWEVER, WHEN ASKED DETAILS REGARDING THE STATEMENT SHE COULDN¿T RECALL THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767524 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention