BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2232378 · Received August 26, 2011

    Report

    Report Number
    2032896-2011-00050
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 17, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA#: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A LITERATURE REPORT FROM (B)(6) WAS RETRIEVED DESCRIBING A (B)(6) MALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). SILVIA P, STEFAN M. RETINAL BRANCH ARTERY OCCLUSION FOLLOWING INJECTION OF HYALURONIC ACID (RESTYLANE). CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY. 2006;34:363-364. MEDICAL HISTORY INCLUDED WRINKLES; TOBACCO USE; CAROTID ARTERY BRUIT AND NO PREVIOUS OCULAR OR SYSTEMIC EPISODES. THE PATIENT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (SYRINGE SIZE AND AMOUNT INJECTED NOT REPORTED) ON AN UNKNOWN DATE IN THE GLABELLAR AREA AND IN THE CHEEKS AS A COSMETIC PROCEDURE FOR WRINKLES. PRE-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNKNOWN DATE, ONE MINUTE AFTER THE LAST INJECTION, THE PATIENT COMPLAINED OF PARTIAL VISUAL LOSS IN THE INFERIOR HALF OF THE VISUAL FIELD OF HIS RIGHT EYE. IN TOTAL, 500 MG OF ACETAZOLAMIDE WERE ADMINISTERED IMMEDIATELY. THE VISUAL ACUITY WAS 6/7.5 FOR THE RIGHT EYE AND INCREASED WITHIN THE FOLLOWING 24 HOURS TO 6/6. A RETINAL BRANCH ARTERY OCCLUSION OF THE SUPERIOR TEMPORAL ARTERY WAS IDENTIFIED. THE EMBOLUS WAS CLEARLY VISIBLE AND LOCATED MORE PERIPHERAL THAN THE DISTRIBUTION OF THE RETINAL OEDEMA WOULD HAVE SUGGESTED, INDICATING DISTAL MOVEMENT AND EXPLAINING THE VISUAL IMPROVEMENT. ARTERIOLAR NARROWING WAS PRESENT IN BOTH EYES. MINIMAL ARTERY BRUIT WAS DETECTED BY CAROTID ARTERY ULTRASONOGRAPHY. AN ARTHEROSCLEROTIC PATHOGENESIS WAS CONSIDERED BECAUSE OF THE PATIENT'S RISK FACTORS INCLUDING TOBACCO ABUSE AND CAROTID ARTERY BRUIT. CHOLESTEROL EMBOLI COULD BE RULED OUT, AS THEY PRESENT AS ORANGE IN COLOUR AND GLOBULAR OR RECTANGULAR. ALSO CALCIFIC EMBOLI WOULD BE DIFFERENT, AS THEY ARE SOLD AND WHITE. THE EMBOLUS IN THIS PATIENT PRESENTED AS A LONG AND FRAGMENTED INTERRUPTION OF THE BLOOD COLUMN SUGGESTIVE OF GEL. THEREFORE, THE AUTHORS SUPPOSED THAT HYALURONIC ACID GEL WAS EMBOLIZED. MOREOVER, THE PATIENT HAD NO FURTHER OCULAR OR SYSTEMIC EMBOLIC EPISODES, NEITHER IN HIS HISTORY NOR DURING THE 18 MONTHS OF FOLLOW UP. THE PATIENT'S VISUAL ACUITY RECOVERED COMPLETELY AND THE VISUAL FIELD DEFECT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN