BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 5 PRO

    MDR report key: 14432195 · Received May 18, 2022

    Report

    Report Number
    3012236936-2022-01294
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 19, 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

    PT. INFO.: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: N/A. THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) HEALON 5 PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: N/A. THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) HEALON 5 PRO IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. (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 HEALON5 PRO OVD (OPHTHALMIC VISCOELASTIC DEVICE), THERE WAS SMALL PARTICLE OF PLASTIC OBSERVED IN THE PATIENT'S LEFT EYE DURING IMPLANTATION OR APPLICATION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, NOR SUTURES REQUIRED. NO DELAY IN PROCEDURE. PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803558 HEALON 5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TV60ML UJ31437 05050474701663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male