BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9434702 · Received December 7, 2019

    Report

    Report Number
    3004750704-2019-00097
    Event Type
    Injury
    Date Received
    December 7, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE DATE ((B)(6) 2019) WAS ENTERED IN THE SECTION ''B4. DATE OF THIS REPORT'' OF THE INITIAL MDR REPORT WHICH IS INCORRECT. THE CORRECT DATE THAT SHOULD HAVE BEEN USED IS (B)(6) 2019''. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ALTERNATE TECHNIQUE DURING SURGERY TO ASPIRATE THE HEALON OUT WAS CARRIED BY IRRIGATION/ASPIRATION BY SURGEON SPENDING MORE TIME ON IT AFTER IOL IMPLANTATION. ALSO DOCTOR HAD TO GO UNDERNEATH THE IOL TO REMOVE HEALON GV PRO, WHICH WAS WHEN THE CAPSULE WAS RUPTURED. THE POSTERIOR CAPSULE WAS ACTUALLY RUPTURED IN 2 PATIENTS WITH THE EXACT SAME SCENARIO. THERE WAS INTERVENTION REQUIRED POST-OPERATIVELY, BOTH PATIENTS REQUIRED DIAMOX 500MG PO X 1 IMMEDIATELY POST-OP AND 250MG PO BID FOR 2 DAYS AFTER WITH PRED FORTE Q2H AND COMBING AM BID FOR 1 WEEK. THERE WAS PATIENT IMPACT POST-OPERATIVELY CAUSING INCONVENIENCE, MORE OCULAR IRRITATION AND ANXIETY IN PATIENT WITH EXACTA DROPS AND PO MED. PATIENTS WITH CAPSULE RUPTURE HAD THEIR IOPS WELL CONTROLLED BY THE MEDICATIONS LISTED. BUT OTHER PATIENTS WITHOUT CAPSULE RUPTURE HAD ELEVATED IOP UP TO 44MMHG. IT WAS ELEVATED 1-DAY POST OP. THE IOP ELEVATED WERE PROMPTLY TREATED WITH ANTERIOR CHAMBER PARACENTESIS AND IOP LOWERING DROPS SO IOP DID NOT REMAIN ELEVATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED, IF EXPLANTED, GIVE DATE: NOT APPLICABLE, HEALON GV PRO IS NOT AN IMPLANTED DEVICE. DEVICE MANUFACTURE DATE: UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. RECALL: 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 WHILE USING HEALON GV PRO THERE WERE INTRAOCULAR PRESSURE SPIKES, AND DIFFICULTY GETTING THE HEALON GV PRO OUT OF THE EYE. THE CAPSULAR BAG BURST BECAUSE OF IT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229404 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other