BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LIQUID OPTICS INTERFACE

    MDR report key: 22628323 · Received July 28, 2025

    Report

    Report Number
    3012236936-2025-000202
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Report Date
    October 29, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    OOE
    UDI-DI
    05050474609761
    PMA / PMN Number
    K170322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE (5) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE (1) INVESTIGATION WAS COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICE AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10 -LIST OF ALL LOT NUMBERS OF THE DEVICES AND QUANTITY. 24129431 (X1), UNKNOWN (X 9), 24477175 (X 5), 24797178 (X1), 24392252 (X1). EIGHT (8) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICE AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685860 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. 0180-1401 05050474609761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown