BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 8485869 · Received April 5, 2019

    Report

    Report Number
    3005675890-2019-00037
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 5, 2019
    Report Date
    November 10, 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
    VA, 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 · 0

    DEVICE MANUFACTURE DATE: ADDITIONAL: IN INITIAL REPORT, THE MANUFACTURER YEAR WAS ONLY PROVIDED, HOWEVER THE FULL DATE IS 3/18/2015. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE INITIAL REPORT, THE EVENT DATE WAS INADVERTENTLY PROVIDED AS (B)(6)2019, HOWEVER, THE EVENT DATE IS (B)(6)2019. THIS FOLLOW UP REPORT HAS THE CORRECT DATE IN SECTION DATE OF EVENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE- YEAR 2015. (B)(4). 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

    ACCOUNT REPORTED THAT THE CAPSULOTOMY DISC BECAME STUCK TO THE POSTERIOR CORNEA DURING THE PHACO PORTION OF THE SURGERY AND THE PATIENT HAD A SECONDARY SURGICAL PROCEDURE ON A DIFFERENT DAY TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279087 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention