BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR S4 IR

    MDR report key: 21433556 · Received February 21, 2025

    Report

    Report Number
    3012236936-2025-000050
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 24, 2025
    Report Date
    March 20, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)3051
    PMA / PMN Number
    P930016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION H3: THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE TO RESOLVE THE ISSUE. FSE REPLACED SEVERAL PARTS TO FIX THE ISSUE. SYSTEM IS PERFORMING TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BASED ON FURTHER REVIEW OF THE COMPLAINT FILE, IT WAS NOTED THAT SECTION H4 DEVICE MANUFACTURE DATE, SECTION H6 COMPONENT CODES, SECTION H6 INVESTIGATION FINDINGS, AND SECTION H6 INVESTIGATION CONCLUSIONS WERE NOT ACCURATE ON THE INITIAL MEDWATCH REPORT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. SECTION H4. DEVICE MANUFACTURE DATE, OCT 13, 1995 SECTION H6. COMPONENT CODES, 451 - ELECTRODE 4736 - FAN/BLOWER 486 - MOTOR(S) 887 - MOUNT 4733 - CONNECTOR/COUPLER 835 - HEAT EXCHANGER 932 - REGULATOR 427 - CIRCUIT BOARD 816 - FILTER SECTION H6. INVESTIGATION FINDINGS, 120 - ELECTRICAL PROBLEM IDENTIFIED 3224 - OPTICAL PROBLEM IDENTIFIED 180 - MECHANICAL PROBLEM IDENTIFIED SECTION H6. INVESTIGATION CONCLUSIONS, 4307 - CAUSE TRACED TO COMPONENT FAILURE ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED HAVING AN ERROR MESSAGE STATING "FLUENCE EXCEEDS NORMAL LIMITS," WHICH NECESSITATED A SPHERE CALIBRATION ON THEIR STAR LASER. SPECIFICALLY, THE LASER PRESENTED A -15.1 FLUENCE OFFSET, REACHING A MAXIMUM OF 16% OF THE TREATMENT FOR THE RIGHT EYE OCULUS DEXTER (OD) OF A DOCTOR OF OPTOMETRY, WITH A PRESCRIPTION OF -2.63 +1.52 X086. THE LASER STOPPED AGAIN AT A -20.1 FLUENCE WITH A MAXIMUM OF 20.1, DISPLAYING THE ERROR: "PLEASE RELEASE THE FOOTSWITCH. TREATMENT STOPPED DUE TO INTERLOCK. FLUENCE EXCEEDS NORMAL LIMITS AT 38%." THE TREATMENT WAS HALTED WITH 33% REMAINING, AND THE ERROR INDICATED THAT THE LASER FLUENCE WAS 20.1% BELOW THE SET VALUE, PROMPTING A NEW DAILY CALIBRATION PROCEDURE. WITH 9 SECONDS LEFT, THE -15.1 FLUENCE OFFSET REAPPEARED, ACCOMPANIED BY A WARNING THAT THE LASER FLUENCE WAS LOWER THAN SET BY 15.1%, WITH THE MAXIMUM OFFSET DURING THE TREATMENT BEING 15.1%. THE SYSTEM DETECTED THAT THE FLUENCE EXCEEDED THE NORMAL RANGE AND AUTOMATICALLY SET THE FLUENCE BEFORE THE NEXT TREATMENT. BEFORE THE OD COMPLETE, CUSTOMER HAD TO REMOVE PATIENT TO DO A SET FLUENCE AND CUT ANOTHER MYOPIC SPHERE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109561 STAR S4 IR EXCIMER LASER SYSTEM LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown