BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 12600994 · Received October 8, 2021

    Report

    Report Number
    2020664-2021-07702
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 16, 2021
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701571
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW, IT WAS NOTICED THAT THE "ESTABLISHMENT NAME" WAS INADVERTENTLY NOT ENTERED IN THE SECTION "E1" OF THE INITIAL MDR REPORT. THEREFORE, THE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION E1: CLINIQUE DE L¿EUROPE, SITE ST ELIZABETH DEVICE EVALUATION: THE MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED EVENT CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. IMPLANT DATE: N/A. THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: N/A. THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA LUER LOCK WAS LOOSE AND COULD NOT BE AFFIXED PROPERLY. THE CANNULA GOT LOOSE FROM THE SYRINGE DURING INJECTION OF THE VISCOELASTIC MATERIAL. NO PATIENT ISSUES WERE REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496316 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB 10290012 UJ31102 05050474701571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown