BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 23700563 · Received December 2, 2025

    Report

    Report Number
    3012236936-2025-000319
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 6, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609792
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . SECTION H3: OUR FIELD SERVICE ENGINEER (FSE) WAS ONSITE FOR A FULL SYSTEM CHECKOUT IN RESPONSE TO REPORTED CAPSULOTOMY TAGS. LASER AND POWER ADJUSTMENT MADE. ATTENUATOR AND EXTERNAL POWER CALIBRATION COMPLETED. VISUAL INSPECTION OF OPTICS REVEALED NO DISCREPANCIES. ROOM HVAC NOT WORKING WHILE TESTING ON 1ST DAY. SYSTEM PASSES ALL FUNCTION AND CALIBRATION SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS DETERMINED THAT SECTION H4, DEVICE MANUFACTURE DATE IN THE INITIAL MDR REPORT, THE DATE WAS INCORRECT. THE CORRECT DATE IS AUG 12, 2014. THEREFORE, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECT DATA. ADDITIONAL NARRATIVE INFORMATION: ASSESSMENTS OF MANUFACTURING, SERVICE, DESIGN, AND USAGE WERE COMPLETED, AND NO PRODUCT QUALITY DEFECTS WERE FOUND. LASER AND POWER ADJUSTMENT MADE. ATTENUATOR AND EXTERNAL POWER CALIBRATION COMPLETED. ROOM HVAC WAS NOT WORKING WHILE TESTING ON THE FIRST DAY. THIS APPEARS TO BE AN ENVIRONMENTAL ISSUE. REVIEWS OF LABELING AND RISK MANAGEMENT FILES WERE CONDUCTED, AND NO NEW ISSUES/RISKS WERE IDENTIFIED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A CAPSULAR RADIAL TEAR OCCURRED AFTER REMOVAL OF THE CAPSULAR DISC DURING A PROCEDURE, NECESSITATING A SUBSEQUENT VITRECTOMY. THE ANTERIOR CAPSULAR RADIAL TEAR OCCURRED AT 3:30 O¿CLOCK WITH POSTERIOR CAPSULAR EXTENSION WITH VITREOUS LOSS IN PATIENT'S LEFT EYE. THE PATIENT IS DESCRIBED AS DOING WELL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2856343 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS-U 05050474609792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention