BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 23336988 · Received October 20, 2025

    Report

    Report Number
    3012236936-2025-000273
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609778
    PMA / PMN Number
    K170322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE INITIAL REPORT THE EXPIRATION DATE AND MANUFACTURING DATE WERE TRANSPOSED THE CORRECT DATES ARE AS FOLLOWS: SECTION D4: EXPIRATION DATE: APR 12, 2027. SECTION H4: DEVICE MANUFACTURE DATE: APR 13, 2025. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT IMPLANTABLE. 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 RECORD 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 THERE WAS NO SUCTION ON THE LIQUID OPTICS INTERFACE (LOI) WHICH OCCURRED DURING DOCKING/PROCEDURE ACTIVATION AND DURING LASER TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999574 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC 0180-1201 60638636 05050474609778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CATALYS S/N: (B)(6).