BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 10536320 · Received September 15, 2020

    Report

    Report Number
    3004750704-2020-00044
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474609662
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN. IF IMPLANTED; GIVE DATE: THE VISCOELASTIC, HEALON PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: THE VISCOELASTIC, HEALON PRO IS NOT AN IMPLANTABLE DEVICE. THEREFORE, NOT EXPLANTED. LAST NAME: UNKNOWN/ NOT PROVIDED. PHONE: (B)(6). THE VISCOELASTIC HEALON PRO IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIBERS WERE FOUND IN BETWEEN 5/10 UNITS OF HEALON PRO TH85ML. IT WAS ALSO REPORTED THAT SOME OF THE PATIENTS WHERE FOUND TO HAVE FIBER STUCK WITHIN THE INCISION DURING THE POST OP EXAMINATION. CUSTOMER IS NOT SURE THAT IT IS COMING FROM THE HEALON PRO AS THE FIBER COULD COME FROM THE TABLE SETTING FOR SURGERIES. NO INFLAMMATIONS OR PATIENT INJURIES WERE REPORTED SO FAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000926 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TH85ML UH31072 05050474609662

    Patients

    Seq Age Sex Outcome Treatment
    1