BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LIQUID OPTICS INTERFACE

    MDR report key: 25038255 · Received April 29, 2026

    Report

    Report Number
    3012236936-2026-000117
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Report Date
    April 30, 2026
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H10 -LIST OF ALL LOT NUMBERS OF THE DEVICES AND QUANTITY: 24084555, 60676872 (X4), 60676877 (X9), UNKNOWN (X2). THREE (3) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING AND TRENDING SHOWED THAT THE DEVICES AND ITS COMPONENTS ALL MET 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 16 MALFUNCTION EVENTS. THE EVENT WAS 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
    260317 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE JOHNSON & JOHNSON SURGICAL VISION, INC. 0180-1401 05050474609761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown