BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9901543 · Received March 30, 2020

    Report

    Report Number
    3004750704-2020-00029
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    December 5, 2019
    Report Date
    October 30, 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
    FR
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). HEALON IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. LAST NAME: UNKNOWN, INFORMATION NOT PROVIDED. (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 THAT DURING THE INJECTION OF THE HEALON GV PRO, THE SURGEON NOTED THE PRODUCT WAS DIFFICULT TO EXPEL AND THAT IT CLOGGED THE HAND PIECE. THE SURGEON REPORTED OF ACUTE AND CHRONIC POST OPERATION HYPERTONIA LEADING TO ABNORMALITIES, POSTOP REFRACTION CORNEAL BURN, DEFORMED PUPIL, INTRAOCULAR PRESSURE (IOP) INCREASES, LENS DISLOCATION, SWELLING OF THE CAPSULAR BAG LEADING TO POST REFRACTION ANOMALIES, BLINDNESS IN A CASE OF GLAUCOMA PATIENT AND HYPERTONIA REQUIRING AN EARLY YTTRIUM-ALUMINUM GARNET (YAG) TREATMENTS. REPORTEDLY, ABOUT ONE HUNDRED (100) PATIENTS ARE AFFECTED. SYMPTOMS WERE TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR FEW PATIENTS WITH CATARACT SURGERY WHO HAD PAIN OVERNIGHT WITH AN INCREASE OF IOP OVER 40/45 MM/HG. DROPS WERE ADMINISTRATED AND SHOWED MINOR DECREASE OF THE IOP. IN ONE SPECIFIC CASE, THE IOP PERSISTED FOR AROUND 2 WEEKS POST OP , WHICH CONSEQUENTLY RESULTED IN IRIS ATROPHY-NECROSIS IS MID DILATATION. QUARTER OF THE IRIS IS NECROSED AND THE PATIENT OUTCOMES IS FINE. IRIS DOES NOT MOVE. ADDITIONALLY, THE CUSTOMER PROVIDED TWO DIFFERENT LOT NUMBERS. DUE THE LIMITED INFORMATION AVAILABLE TO DATE, IT WAS NOT POSSIBLE TO OBTAIN THE BATCH NUMBER RELATED TO THIS SPECIFIC CASE. THIS REPORT WILL PERTAINS TO THE HEALON GV PRO, LOT NUMBER UE3128. A SEPARATE REPORT WILL BE SUBMITTED ON THE LOT NUMBER UE31098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362771 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UE31283 05050474651593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention