BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 24737868 · Received March 30, 2026

    Report

    Report Number
    3012236936-2026-000081
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 19, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474540231
    PMA / PMN Number
    K063682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE. DEVICE EVALUATION: A FIELD SERVICE ENGINEER VISITED AND PERFORMED A PREVENTATIVE MAINTENANCE. SYSTEM 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.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT RASTER PATTERN WAS COMPLETE BUT EXPERIENCED "ENERGY ERROR-RECOVERY IN PROGRESS." EXPERIENCED THE SAME ERROR MESSAGE 3 TIMES CLEARED THE ERRORS AND COMPLETED THE TREATMENT. SAME MESSAGES OCCURRED FOR THE LEFT EYE AND REALIZED THE SIDECUT WAS NOT CREATED FOR THE LEFT EYE AND ONLY HALF OF THE SIDECUT WAS COMPLETED FOR THE RIGHT EYE . PROGRAMMED SIDECUT ONLY RIGHT EYE AND EXPERIENCED SAME ERROR MESSAGE. CUSTOMER CALLED TECH SUPPORT AND COACHED TECHNICIAN ON USING THE "ENABLE TEST MODE," AND CONFIRMED THE ERROR DID NOT OCCUR DURING THE TEST MODE. ERROR ENERGY FAILURE APPEARED ONCE THE TECH DISABLED THE "TEST MODE." THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT PATIENT WAS UNINJURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614967 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20005K 05050474540231

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male