BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 7496489 · Received May 8, 2018

    Report

    Report Number
    3005675890-2018-00024
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    April 5, 2018
    Report Date
    August 13, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT SHOWS NO FAILURE DETECTED. A DOCUMENT LABELING, TRENDING AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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. MANUFACTURING YEAR 2016. FIELD SERVICE SPECIALIST VISITED ACCOUNT AND PERFORMED FULL CHECK OF SYSTEM. INCREASED THE LASER HEAD AMPLIFIER CURRENT DUE TO A POWER DROP FROM THE LASER HEAD. INSPECTED BLUE AND BLACK FIBERS - FOUND OK. CHECKED AND PERFORMED MINOR ADJUSTMENT OF LASER BEAM ALIGNMENT. PERFORMED NEW POWER CALIBRATION. ADJUSTED OFFSET AND PERFORMED NEW OCT ADJUSTMENT. FINAL TEST, DAILY ALIGNMENT VERIFICATIONS AND MOCK TREATMENTS ON PLASTIC EYE AND FOUND SYSTEM WORKING PER JNJ SPECS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A BROKEN CAPSULAR BAG DURING PHACO/IRRIGATION-ASPIRATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337562 CATALYS SYSTEM CATALYS OOE JOHNSON & JOHNSON SURGICAL VISION, INC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other