BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV

    MDR report key: 9549344 · Received January 3, 2020

    Report

    Report Number
    3004750704-2020-00002
    Event Type
    Injury
    Date Received
    January 3, 2020
    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
    PA, 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 (B)(4) AND (B)(4) .

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE CONFIRMED. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE IOL SERIAL NUMBER IS UNKNOWN. HISTORICAL DATA ANALYSIS: THE COMPLAINT HISTORY WAS NOT REVIEWED SINCE THE IOL SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION, CONSIDERING THE LIMITED INFORMATION AVAILABLE IT CANNOT BE DETERMINED IF THERE IS A PRODUCT MALFUNCTION. THE REPORTED ISSUE COULD NOT BE VERIFIED AS PRODUCT WAS NOT RETURNED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DATE OF EVENT: EXACT DATE NOT PROVIDED, BEST ESTIMATE (B)(6) 2019. LOT NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS HEALON GV IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS HEALON GV IS NOT AN IMPLANTABLE DEVICE. DEVICE MANUFACTURE DATE (MM/DD/YYYY): UNKNOWN, AS PRODUCT LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS INJECTED WITH HEALON GV, LOT NUMBER UNKNOWN, IN THE OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. ON (B)(6) 2019 THE ENTIRE ANTERIOR CHAMBER (AC) LOOKS LIKE IT HAS SUSPENDED PIGMENT CELLS. THE PATIENT PRESENTED AFTER GLAUCOMA SURGERY WITH A FLATTENED CHAMBER; THE CHAMBER WAS REFORMED WITH HEALON GV AND GOT INTRAOCULAR PRESSURE (IOP) UP TO 17MMHG. SUBSEQUENT TO THAT, THE PATIENT RETURNED TO OFFICE WITH VERY HIGH INTRAOCULAR PRESSURE (AS HIGH AS 57), AND SIGNS THAT THERE IS STILL MUCH GV IN THE AC. RANGE OF PRESSURE IN PATIENT¿S OD PRIOR TO (B)(6) WAS 24MMHG TO 36MMHG. ON (B)(6) 2019 IOP 13. ON (B)(6) 2019 IOP 36. ON (B)(6) 2019 IOP 50. ON (B)(6) 2019 56 AND THEY TAPPED THE INCISION TO LOWER. ON (B)(6) 2019 IOP 8 AND OS WAS SIMILAR. THE PATIENT¿S VISION IN BOTH EYES IS HAND MOTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11531 HEALON GV OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON GV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention