BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9782375 · Received March 3, 2020

    Report

    Report Number
    3004750704-2020-00017
    Event Type
    Injury
    Date Received
    March 3, 2020
    Report Date
    November 2, 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
    ES
    Reporter Occupation
    PHARMACIST

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF IMPLANTED; GIVE DATE: NOT APPLICABLE. THE HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NOT APPLICABLE. THE HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. (B)(6). (B)(4). 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

    IT WAS REPORTED AFTER A POST OPERATIVE CATARACT SURGERY, A PATIENT SUFFERED HYPERTENSIVE OCULAR CRISIS AND CYSTOID MACULAR EDEMA IN BOTH THE EYES. AFTER FOLLOW-UP, NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243667 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UE31204 05050474651593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other