BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 5 PRO

    MDR report key: 14366015 · Received May 11, 2022

    Report

    Report Number
    3012236936-2022-01249
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 18, 2022
    Report Date
    December 3, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701663
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT AND ETHNICITY: UNKNOWN, INFORMATION NOT AVAILABLE. IMPLANT DATE: IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS HEALON 5 PRO IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS HEALON 5 PRO IS NOT AN IMPLANTABLE DEVICE. (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, 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

    IT WAS REPORTED THAT AFTER INJECTION OF THE OPHTHALMIC VISCOELASTIC MATERIAL (HEALON5 PRO) A SMALL PARTICLE OF PLASTIC WAS OBSERVE IN THE PATIENT'S OPERATIVE EYE. NO PATIENT INJURY WAS REPORTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT HAS REPORTEDLY FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083542 HEALON 5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TV60ML UJ31437 05050474701663

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female