BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR S4 IR

    MDR report key: 23764196 · Received December 9, 2025

    Report

    Report Number
    3012236936-2025-000331
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    March 20, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P910062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H11. CORRECTED DATA: UPON REVIEWING THE INFORMATION RECEIVED, THE UNCONTROLLED CHAIR MOVEMENT DID NOT OCCUR DURING THE USE OF THE STAR EXCIMER LASER. THIS CASE IS NO LONGER CONSIDERED A REPORTABLE MALFUNCTION. THEREFORE, THIS FOLLOW-UP #2 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MEDWATCH REPORT NUMBER 3012236936-2025-0003313. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: PRODUCT INVESTIGATION WAS COMPLETED AND ADDITIONAL COMPONENT CODES WERE PROVIDED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. SECTION H6 - COMPONENT CODES: COMPONENT CODE 423 - CABLE, ELECTRICAL. COMPONENT CODE 866 - LENSES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5, AND A6: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE DEVICE. SECTION H3: OUR FIELD SERVICE ENGINEER (FSE) WAS ONSITE FOR SERVICE. FSE REPLACED THE JOYSTICK CABLES FROM THE JOYSTICK TO THE REMOTE PRINTED CIRCUIT BOARD (PCB) INSIDE THE DIRECT CURRENT (DC) BOX. FSE REPLACED THE EMI DB9 FILTER INSIDE THE DC BOX. FSE ALSO REPLACED THE LENS (L2) AND OUTPUT COUPLER OPTICS. SYSTEM MEETS MANUFACTURERS SPECIFICATIONS. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR BED WAS MOVING. FOLLOWING OUR FIELD SERVICE ENGINEER (FSE) VISIT TO PERFORM REPAIRS, THE CUSTOMER STATED, "EVERYTHING IS FUNCTIONING WELL, NO ISSUES. WE HAVE COMPLETED ONE TREATMENT AFTER THE REPAIR, AND THERE WERE NO PROBLEMS WITH THE BED MOVING. THE BED MOVEMENT DID NOT IMPACT PATIENT OUTCOMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866891 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-4864 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown