BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 18996390 · Received March 28, 2024

    Report

    Report Number
    3012236936-2024-00671
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 27, 2024
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474761360
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. HEALON PRO IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. HEALON PRO IS NOT AN IMPLANTABLE DEVICE. SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3 - OTHER (81): THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN INJECTING THE HEALON PRO INTO THE PATIENT'S OPERATIVE EYE, 2 BLACK THREADS ENTERED THE ANTERIOR CHAMBER. THEY WERE REMOVED WITH TWEEZERS. THE PATIENT WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928373 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UM31664 05050474761360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown