BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9439259 · Received December 9, 2019

    Report

    Report Number
    3004750704-2019-00100
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    October 23, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Removal / Correction Number
    2020664-12/02/19-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. LOT NUMBER : UNKNOWN. EXPIRATION DATE : UNKNOWN. UNIQUE IDENTIFIER (UDI) : UNKNOWN. 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. (B)(6). DEVICE MANUFACTURE DATE : UNKNOWN. 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 REGARDING 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 THERE ARE SIX CATARACT PATIENTS THAT HAVE EXPERIENCE HIGH INTRAOCULAR PRESSURE (IOP) THAT REQUIRED MEDICAL INTERVENTION WHEN USING VISCOELASTIC HEALON GV PRO. A HOSPITAL IS REPORTING SINCE CHANGING OUT THE VISCOELASTIC FROM HEALON GV TO HEALON GV PRO DURING THE MONTH OF (B)(6) 2019, THEY HAVE PATIENTS PRESENTED WITH AN INCREASE IN INTRAOCULAR PRESSURE (IOP) AFTER HAVING A CATARACT PROCEDURE THAT ARE DISCOVERED AT A POST OP EXAM. THE TREATING SURGEON INDICATED THE HEALON GV PRO WERE USED IN NORMAL CATARACT PROCEDURES. THE PROCEDURES DONE WITHOUT ANY COMPLICATIONS. THE VISCOELASTIC WAS ASPIRATED BY GOING UNDER LENS AND/OR ROCKING THE LENS AND IRRIGATED WITH BALANCE SALT SOLUTION (BSS). THE HIGH IOPS ARE DISCOVERED AT FOLLOW UP POST OP EXAMS. THE SURGEON COMMENTS WERE THAT THE POSSIBLE CAUSE OF THE HIGH IOP WAS RELATED TO THE USAGE OF HEALON GV PRO. SOME OF THE CASES REQUIRE A STAY OVER IN HOSPITAL FOR PRESSURE RELEASES. A MANUAL PRESS RELEASE THROW WOUND WITH NEEDLE AND MEDICATION ARE REQUIRED TO RELEASE PRESSURE. THE IOP¿S WERE STABILIZED AND THE PATIENTS ARE DISCHARGED. THE PATIENT OUTCOMES ARE REPORTED AS NO LONG TERM IMPACTED. THE PATIENTS WILL BE MONITORED WITHIN A FEW WEEKS IF NEEDED. THE PRODUCT REPORTED WAS DISCARDED. ALL THE INFORMATION AVAILABLE WERE SUBMITTED. THIS REPORT IS FOR PATIENT NO. 2. A TOTAL OF 6 SEPARATE REPORTS WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235918 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention