BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9556359 · Received January 7, 2020

    Report

    Report Number
    3004750704-2020-00003
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    November 13, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474651654
    PMA / PMN Number
    P810031
    Removal / Correction Number
    2020664-12/02/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS DEVICE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS DEVICE IS NOT AN EXPLANTABLE DEVICE. CONCOMITANT PRODUCTS: INTRAOCULAR LENS, MODEL ZA9003, SN (B)(4); UNFOLDER CARTRIDGE, MODEL EMERALDC30, LOT# UNKNOWN; WHITESTAR SIGNATURE SYSTEM, MODEL NGP680300, SN UNKNOWN; PHACO HANDPIECE/TIP, MODEL/SERIAL NUMBER 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 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

    THE SURGERY CENTER REPORTED OF A CORNEAL BURN EVENT. THE NUCLEAR MATERIAL WAS REMOVED WITH THE WHITESTAR SYSTEM, THAT A SMALL CORNEAL BURN WAS NOTED DURING EARLY GROOVING AT THE MAIN INCISION. IT WAS INDICATED THAT THE PHACO POWER WAS VERY LOW AND THAT THE CATARACT WAS NOT A DIFFICULT CATARACT; HOWEVER, THE CUSTOMER HAD DIFFICULTIES USING THE HEALON GV PRO AND THE PHACO HANDPIECE WOULD GET CLOGGED. IT WAS NOTED THAT AT THE END OF THAT DAY, DURING CLEANING OF THE HANDPIECE/TIP THERE WERE DRIED RESIDUAL HEALON ON TOP OF THE HANDPICE TIP. REPORTEDLY, THERE WAS NO CORNEAL BURN AT THE DAY ONE (1), THE EYE WAS CLEAR AND THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THERE WAS NO LOSS OF BEST-CORRECTED VISUAL ACUITY (BCVA) AND NO INCREASE IN THE INTRAOCULAR PRESSURE (IOP). THE ACCOUNT NOTED THAT THE HEALON GV PRO PRODUCT WHICH WAS ON THE LISTED RECALL LIST WAS USED FOR THIS SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22847 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UE31521 05050474651654

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other