BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID, HYALURONIC ACID

    MDR report key: 3902265 · Received June 25, 2014

    Report

    Report Number
    2032896-2014-00503
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS ALSO LINKED TO FOUR OTHER CASES: (B)(4). CHEN Y, WANG W, LI J, YU YI, LI L, LU N. FUNDUS ARTERY OCCLUSION CAUSED BY COSMETIC FACIAL INJECTIONS. CHIN MED J (ENGL). 2014; 127 (8): 1434-7. FOLLOW UP LETTER (1) SENT ON (B)(6) 2014. FOLLOW UP LETTER (2) SENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2014 VIA A LITERATURE ARTICLE AND CONCERNED A (B)(6) FEMALE PATIENT. THE PATIENT WAS HEALTHY WITHOUT HYPERTENSION, DIABETES, AND OTHER UNDERLYING DISEASES. HER MEDICAL HISTORY WAS RELEVANT FOR COSMETIC FACIAL FILLER INJECTION IMMEDIATELY BEFORE FUNDUS ARTERY OCCLUSION AND NONARTERITIC RETINAL ARTERY OCCLUSION NEWLY DIAGNOSED BY FUNDUS FLUORESCEIN ANGIOGRAPHY. SHE SHOWED NO HISTORY OF INTRAOCULAR SURGERY OR RETINAL ARTERY OCCLUSION BEFORE SYMPTOM DEVELOPMENT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED HYALURONIC ACID COSMETIC FACIAL INJECTION 0.6 ML IN THE UPPER EYELID AREA NEAR THE LEFT EYE. THE SIZE OF THE NEEDLE USED FOR INJECTION WAS REPORTED AS 30 GAUGE. THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNSPECIFIED DATE, AFTER THE HYALURONIC ACID INJECTION, THE PATIENT EXPERIENCED OPHTHALMIC ARTERY OCCLUSION (OAO). THE ASSOCIATED OCULAR SYMPTOMS INCLUDED PTOSIS, OPHTHALMOPLEGIA, DIZZINESS AND VOMITING. THE FUNDUS SHOWED THINNING AND SEGMENTED CENTRAL RETINAL ARTERY AND PALE AND DIFFUSE EDEMATOUS RETINA WITHOUT CHERRY-RED SPOT. FUNDUS FLUORESCEIN ANGIOGRAPHY SHOWED NO RETINAL AND CHOROID PERFUSION IN THE EARLY STAGE. THE INITIAL AND FINAL BCVA SHOWED NO LIGHT PERCEPTION. THE PATIENT WAS TREATED IMMEDIATELY AFTER THE ONSET OF VISUAL LOSS; HOWEVER, THE PATIENT HAD POOR VISUAL OUTCOME DESPITE THE TREATMENT. BCVAS (NO LIGHT PERCEPTION) OF THE PATIENT REMAINED UNCHANGED DURING FOLLOW-UP. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. ALL OF THE INJECTION SITES IN THE FACE MIGHT CAUSE ARTERY OCCLUSION; THEREFORE, PATIENTS SHOULD BE INFORMED ABOUT THE RISK OF IRREVERSIBLE BLINDNESS FROM FUNDUS ARTERY OCCLUSION, AND THE INJECTIONS SHOULD BE PERFORMED CAREFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370291 HYALURONIC ACID, HYALURONIC ACID INJECTABLE DERMAL FILLER LMH MEDICIS AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR