BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7894869 · Received September 20, 2018

    Report

    Report Number
    3005675890-2018-00079
    Event Type
    Injury
    Date Received
    September 20, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    ADDITIONAL INFORMATION: SURGEON REPORTED THAT PATIENT DID FINE EXCEPT BEING MYOPIC (NEARSIGHTED) DUE TO LENS POWER IMPLANTED IN SULCUS. APPLICATION SUPPORT MANAGER VISITED THE SITE AND WAS ABLE TO REVIEW THE TREATMENT PLAN FOR THE PATIENT. HE DID NOT NOTE ANY MISPLACEMENT OF THE SURFACE MAPS. HE WAS UNABLE TO DISCUSS WITH THE DOCTOR AS SHE WAS NOT AT THE SITE THAT DAY. PATIENT CODE - (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K121091. DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. 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 AFTER THE SURGEON COMPLETED THE CATALYS PROCEDURE AND WHEN THE PATIENT CAME IN FOR THE CATARACT PORTION OF THE CASE THERE WERE ISSUES WITH THE POSTERIOR CAPSULE BAG. THIS PATIENT WAS THEN REFERRED TO A RETINA SPECIALIST. THE SURGEON AND THE RETINA SURGEON BELIEVE THE ISSUE IT MAY HAVE BEEN CAUSED BY THE CATALYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733566 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other