BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 9108761 · Received September 24, 2019

    Report

    Report Number
    3004750704-2019-00038
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    August 24, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    15050474500072
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 (B)(4) AND (B)(4) .

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTS THE PATIENT HAS RETURNED TO NORMAL VALUES OF 18MM HG ON SEPTEMBER 2, 2109. PATIENT DOES NOT HAVE A HISTORY OF GLAUCOMA. THE EVENT WAS CONSIDERED AS NOT SERIOUS BY THE INVESTIGATOR OF THE STUDY. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, NOT PROVIDED. GENDER/SEX: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATES: NOT APPLICABLE, HEALON IS NOT AN IMPLANTED DEVICE. IF EXPLANTED; GIVE DATES: NOT APPLICABLE, HEALON IS NOT AN IMPLANTED DEVICE. (B)(6). THE PRODUCT IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STUDY PATIENT EXPERIENCED ISSUES WITH HEALON PRO. ELEVATED INTRAOCULAR PRESSURE (IOP) OF 40 MM HG. THE PATIENT ATTENDED THE (B)(6) STUDY VISIT (B)(6) 2019 AND IOP WAS MEASURED AT 15 MM HG IN THE LEFT EYE. THE SUBJECT HAD CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2019. THE HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS USED DURING SURGERY. AT THE 1-DAY POSTOPERATIVE STUDY VISIT (B)(6) 2019, THE PATIENT HAD A SPIKE IN IOP (40 MM HG). THE OCULAR HYPERTENSION WAS TREATED WITH IOPIMAX. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905343 HEALON OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 0.85 UD31153 15050474500072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention