BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9536126 · Received December 31, 2019

    Report

    Report Number
    3004750704-2019-00118
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    November 15, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474651593
    PMA / PMN Number
    P810031
    Removal / Correction Number
    2020664-12/02/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    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

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. (B)(6). IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE VISCOELASTIC (OVD) IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE VISCOELASTIC (OVD) IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. THIS COMPLAINT IS PART OF THE RECALL - REPORT NUMBER 2020664-12/02/19-001-R: JOHNSON & JOHNSON SURGICAL VISION (JJSV) ISSUED A VOLUNTARY RECALL ON NOVEMBER 22, 2019. IT HAS BEEN REPORTED CUSTOMERS HAVE DESCRIBED HEALON GV PRO AS BEHAVING DIFFERENTLY THAN THE LEGACY HEALON GV, ESPECIALLY IN REGARD TO THE TECHNIQUES REQUIRED TO REMOVE THE PRODUCT FROM THE EYE. AN INCREASE OF INTRA-OCULAR PRESSURE (IOP) IS REPORTED IF THERE ARE SMALL AMOUNTS OF HEALON GV PRO REMAINING BEHIND THE OPERATIVE EYE. THIS VOLUNTARY RECALL IS BEING INITIATED DUE TO RECEIVED REPORTS OF HEALON GV PRO BEING DIFFICULT TO REMOVE FROM THE EYE, LEADING TO INCREASED POST-OPERATIVE IOP REQUIRING ADDITIONAL INTERVENTION. POTENTIAL CLOGGING OF PHACOEMULSIFICATION EQUIPMENT TUBING HAS ALSO BEEN REPORTED, WHICH MAY LEAD TO DELAY IN THE PROCEDURE OR OCULAR INJURY. THERE ARE TWENTY-ONE AFFECTED LOT NUMBERS. THE RECALL NOTIFICATION LETTER HAS BEEN SENT TO ALL CUSTOMERS INSTRUCTING THEM TO RETURN THE UNITS OF HEALON GV PRO FROM THE TWENTY-ONE (21) AFFECTED LOTS. JOHNSON & JOHNSON SURGICAL VISION HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO INVESTIGATE AND ADDRESS THE ISSUE. ACTION ITEMS GENERATED FROM THE CAPA WILL BE SUBMITTED IN THE FUTURE INTERIM REPORT(S) AS PART OF THE RECALL PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329106 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UE31476 05050474651593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention