BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 5 PRO

    MDR report key: 16109503 · Received January 5, 2023

    Report

    Report Number
    3012236936-2023-00048
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 12, 2022
    Report Date
    January 5, 2023
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE HEALON5 PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE HEALON5 PRO IS NOT AN IMPLANTABLE DEVICE. THEREFORE, IT WAS NOT EXPLANTED. 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. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION AS WELL AS ADDITIONAL INFORMATION REGARDING THE COMPLAINT; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) HAD A WHITE SUBSTANCE THAT WAS SEEN ENTERING THE EYE. THE INTRAOCULAR LENS (IOL) IN USE WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE DUE TO THE OVD ISSUE. ACCOUNT INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL INTERVENTION REQUIRED. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502710 HEALON 5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TV60ML UK31403 05050474701663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IOL, UNKNOWN SERIAL #.