BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 9387650 · Received November 27, 2019

    Report

    Report Number
    3004750704-2019-00089
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6: RESULTS CODE: 114 IS FOR OPERATIONAL PROBLEM IDENTIFIED? SECTION H6: CONCLUSION CODE 4316 IS PROVIDED AS COMPLAINT IS RELATED TO A FIELD ACTION. SECTION H9: 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. H3 OTHER TEXT : PLACEHOLDER.

    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

    LOT NUMBER: UNKNOWN/NOT PROVIDED. CATALOG#: UNKNOWN, AS PRODUCT LOT NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT APPLICABLE. HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT APPLICABLE. HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE ACCOUNT; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT 5 PATIENTS HAD HYPERTONIA AND HIGH INTRAOCULAR PRESSURE (IOP) ON POSTOP DAY 1 WITH SYMPTOMS OF PAIN AND NAUSEA. ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR STATED THAT SEVERAL OF HIS PATIENTS HAD INCREASED INTRAOCULAR PRESSURE FOLLOWING THE USE OF HEALON GV PRO DURING THEIR CATARACT PROCEDURES. HE STATED THERE WERE AT LEAST 3 PATIENTS THAT HAD ADVERSE EVENTS ASSOCIATED WITH THE INCREASED PRESSURE, ONE PATIENT HAD AN INTRAOCULAR PRESSURE POSTOPERATIVELY OF 35 AND ANOTHER PATIENT HAD A PRESSURE OF 66 AND HAD SOME SWELLING AROUND THE OPTIC NERVE, BOTH OF WHICH ALSO EXPERIENCED VISUAL LOSS. IT IS UNKNOWN AT THIS POINT WHICH PATIENT HAD HOW MUCH OF SEVERITY. THIS REPORT CAPTURES INFORMATION FOR 1 PATIENT. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER 4 PATIENTS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178823 HEALON GV PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TG85ML UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other