BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON DUET PRO

    MDR report key: 8602132 · Received May 10, 2019

    Report

    Report Number
    3004750704-2019-00015
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    April 9, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND (B)(4) .

    Additional Manufacturer Narrative · 1

    LOT#: UNKNOWN/NOT PROVIDED. CATALOG#: UNKNOWN, AS PRODUCT LOT NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). OVD IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). OVD IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA HAD POPPED OFF OF THE SYRINGE ON THE HEALON DUET PRO - OPHTHALMIC VISCOSURGICAL DEVICE (OVD) DURING INSERTION. THERE IS INDICATION THAT THE ISSUE WAS ATTRIBUTED TO USE ERROR AS THE SURGEON MENTIONED THAT SHE DID NOT KNOW IF THE TECHNICIAN HAD PREPARED THE DEVICE PROPERLY. THE PATIENT EXPERIENCED ISSUES WITH THE IRIS AS WELL AS A CAPSULE TEAR. THE SURGEON HAD TO PERFORM A CAPSULOTOMY SINCE IT HAD TORN OUT TO THE LENS EQUATOR INFERIORLY. THE SURGEON GENTLY PERFORMED HYDRO-DISSECTION AND REMOVED THE LENS. SHE HAD TO POSITION THE LENS WITH THE HAPTICS 90 DEGREES AWAY FROM THE CAPSULAR TEAR AND EVACUATED THE IRIS HEMORRHAGE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394318 HEALON DUET PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention