BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 8403797 · Received March 8, 2019

    Report

    Report Number
    3005675890-2019-00031
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    August 2, 2018
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    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

    SERIAL NUMBER: (B)(4). UNIQUE IDENTIFIER (UDI#): (B)(4). MANUFACTURING DATE: THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS FEBRUARY 28, 2013.

    Additional Manufacturer Narrative · 1

    CITATION: YONG, W., CHAI, H., SHEN, L., MANOTOSH, R. AND ANNA TAN, W. (2018). COMPARING OUTCOMES OF PHACOEMULSIFICATION WITH FEMTOSECOND LASER¿ASSISTED CATARACT SURGERY IN PATIENTS WITH FUCHS ENDOTHELIAL DYSTROPHY. AMERICAN JOURNAL OF OPHTHALMOLOGY, 196, PP.173-180. SERIAL#: UNKNOWN/NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (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

    IT WAS REPORTED THAT A PATIENT HAD EDEMA THAT PROGRESSED TO PSEUDOPHAKIC BULLOUS KERATOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196886 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC. CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other