BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 15709312 · Received November 1, 2022

    Report

    Report Number
    3012236936-2022-02712
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 1, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (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) # K113479. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NUCLEUS DROP FROM POSTERIOR LENS WAS REPORTED IN PATIENT WHO UNDERWENT CATALYS PROCEDURE. VITRECTOMY WAS PERFORMED. SUTURES WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483148 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention