BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 23253826 · Received October 9, 2025

    Report

    Report Number
    3012236936-2025-000264
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INITIAL REPORT WAS INADVERTENTLY SUBMITTED AS WE INITIALLY HAD INFORMATION THAT INDICATED THERE WAS NO CONTACT BETWEEN THE PATIENT INTERFACE AND THE PATIENT; THEREFORE THIS IS A NOT REPORTABLE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS REPORTED VIA EMAIL ON 10/9/25 THAT PATIENT INTERFACE HAD NO CONTACT WITH THE PATIENT. THE EVENT IS NO LONGER A REPORTABLE EVENT. THEREFORE, THIS FOLLOW-UP #1 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MEDWATCH REPORT NUMBER 3012236936-2025-0002642.

    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 E1. TELEPHONE NUMBER, +1(877)266-4543 SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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

    CUSTOMER REPORTED TWO INTRALASE PATIENT INTERFACE CONES HAVING WHITE DEPOSITS ON THEIR LENSES. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646125 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60567517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown