BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE

    MDR report key: 6725507 · Received July 19, 2017

    Report

    Report Number
    1000118068-2017-00056
    Event Type
    Injury
    Date Received
    July 19, 2017
    Report Date
    July 3, 2017
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION: THE EVENTS ARE COVERED BY CURRENT LABELLING FOR THE COMPANY'S HYALURONIC ACID FILLERS. MANUFACTURER NARRATIVE: THE CASE REPORT PERTAINS TO UNSPECIFIED HYALURONIC ACID FILLER AND RESTYLANE. TRENDING ON LOT NUMBER OR BATCH RECORD REVIEW COULD NOT BE PERFORMED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF BLINDNESS UNILATERAL, PTOSIS AND VASCULAR OCCLUSION INJURY WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THIS CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO REGULATORY AUTHORITIES DUE TO THE MEDICAL AND SURGICAL INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Description of Event or Problem · 1

    THIS CASE WITH REFERENCE NUMBER (B)(4) WAS OBTAINED FROM LITERATURE ON 03-JUL-2017 VIA E-MAIL. REFERENCE: MYUNG Y1, YIM S, JEONG JH, KIM BK, HEO CY, BAEK RM, PAK CS.. THE CLASSIFICATION AND PROGNOSIS OF PERIOCULAR COMPLICATIONS RELATED TO BLINDNESS FOLLOWING COSMETIC FILLER INJECTION. PLAST RECONSTR SURG. 2017 JUL;140(1):61-64. THIS PATIENT IS ONE OF 9 PATIENTS INCLUDED IN THE ARTICLE. THE PATIENTS WERE SELECTED BASED ON: A HISTORY OF RECEIVING HYALURONIC ACID FILLER INJECTION, BLINDNESS AND PERIOCULAR SYMPTOMS OCCURRING RIGHT AFTER FILLER INJECTION, AND SYMPTOMS LIMITED TO ONE EYE, FOR COMPARISON WITH THE UNAFFECTED CONTRALATERAL SIDE. THE TYPES OF INJECTED HYALURONIC ACID FILLERS WERE RESTYLANE (GALDERMA S.A., (B)(4)) IN FOUR CASES, YVOIRE (LG LIFESCIENCES, (B)(4)) IN THREE CASES, AND JUVÉDERM (ALLERGAN, INC., (B)(4)) AND NEURAMIS (MEDYTOX, INC., (B)(4)) IN ONE CASE EACH. (TWO OF THE CASES HAVE PREVIOUSLY BEEN REPORTED IN ARTICLE WITH REFERENCE: YONG-KYU KIM, CHEOLKYU JUNG, SE JOON WOO, KYU HYUNG PARK JOURNAL OF KOREAN MEDICAL SCIENCE DOI: 10.3346/JKMS.2015.30.12.18472015 "CEREBRAL ANGIOGRAPHIC FINDINGS OF COSMETIC FACIAL FILLER-RELATED OPHTHALMIC AND RETINAL ARTERY OCCLUSION"). AS A CONSERVATIVE APPROACH ALL OF THE OTHER 7 CASES HAVE BEEN ENTERED AS RESTYLANE CASES UNTIL CONFIRMATION ON PRODUCT USED IN EACH CASE HAS BEEN RECEIVED. THIS PATIENT, A WOMAN OF UNKNOWN AGE UNDERWENT INJECTION TREATMENT WITH OF 0.1-1 ML OF AN UNCONFIRMED HYALURONIC ACID FILLER TO THE GLABELLA, NASOLABIAL FOLD /NASAL DORSUM AREA. SHE EXPERIENCED PTOSIS WITH BLINDNESS IN THE AFFECTED EYE THAT WAS NOT ACCOMPANIED BY EXTRAOCULAR MUSCLE WEAKNESS OR EYEBALL MOVEMENT LIMITATION. ON EXOPHTHALMOMETRY, NO DIFFERENCE BETWEEN THE TWO EYES (21/21 MM) WAS NOTED ON THE INITIAL VISIT IMMEDIATELY AFTER VASCULAR OCCLUSION INJURY, BUT AFTER 6 MONTHS, THE LEFT EYEBALL DEMONSTRATED AN AVERAGE 1-MM POSTERIOR DISPLACEMENT COMPARED WITH THE UNINVOLVED CONTRALATERAL SIDE (21/20 MM). BY CONTRAST, LEVATOR FUNCTION OF THE PATIENT SHOWED DRAMATIC IMPROVEMENT 6 MONTHS AFTER INJURY, AND EYEBALL MOVEMENT REMAINED NORMAL DURING THE FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505883 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention