BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEIBOMIAN GLAND EVALUATOR

    MDR report key: 22458471 · Received July 9, 2025

    Report

    Report Number
    3012236936-2025-000188
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 16, 2025
    Report Date
    February 23, 2026
    Manufacturer
    TEARSCIENCE, INC.
    Product Code
    HKI
    UDI-DI
    00859623006919
    PMA / PMN Number
    K182506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 A3, A4 AND A5: NOT APPLICABLE. 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. 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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE DEVICE WAS REPAIRED BY REPAIRING THE DEFECTING CENTRAL PROCESSING UNIT (CPU) AS THE C22 HAD SHORTED OUT AND BURNED. SYSTEM PERFORMING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H4 - DEVICE MANUFACTURE DATE: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 08/20/2018, HOWEVER THE CORRECT DATE IS 01/22/2018. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS IT CANNOT BE DETERMINED THAT THE ISSUE IS TRACED TO THE DESIGN, MANUFACTURING, OR LABELING, PRODUCT DEFICIENCY CANNOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION WAS CONFIRMED AND A NON-CONFORMANCE INVESTIGATION WAS CONDUCTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM WAS SITTING IDLE AND A PUFF OF SMOKE CAME OUT AND THEIR WAS A BURNING SMELL AND NOW WILL NOT POWER ON. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117570 MEIBOMIAN GLAND EVALUATOR CAMERA, OPHTHALMIC, AC-POWERED HKI TEARSCIENCE, INC. DMI-1000 00859623006919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown