BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3232295 · Received July 11, 2013

    Report

    Report Number
    2032896-2013-00283
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 2, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SEVERE AND PERSISTENT ADVERSE EFFECTS CAN OCCUR INCLUDING TISSUE NECROSIS, RETINAL ARTERY OCCLUSION, AND BRAIN INFARCTION. THEREFORE, COSMETIC PROCEDURES SHOULD BE CAREFULLY PERFORMED ADMINISTERING PERIOCULAR DERMA FILLER INJECTION. A PROMPT CONSULTATION WITH AN OPHTHALMOLOGIST IS RECOMMENDED WHEN THERE ARE VISUAL PROBLEMS AFTER INJECTION. THE COMPANY'S CAUSALITY ASSESSMENT IS THAT THE CASE IS ONE OF THE MOST SEVERE CASES AMONG THE RARE REPORTS ON ACCIDENTAL INTRAVASAL INJECTION OF A SUBSTANCE TO AN ARTERY WITH ANASTOMOSE TO THE BRANCHES OF OPHTHALMIC ARTERIES. AS SIMILAR ADVERSE EVENTS ALSO CAN OCCUR AFTER AUTOLOGUE FAT INJECTION AND OTHER SUBSTANCES IN THE SAME AREA, WE FIND THIS ADVERSE EVENT RELATED TO THE INJECTION PROCEDURE AND NOT SPECIFICALLY THE PRODUCT. HOWEVER, DUE TO ITS SEVERITY THE CASE REPORT IS ASSESSED AS A SERIOUS ADVERSE EVENT. PHARMACOVIGILANCE_COMMENT: PB ON (B)(6) 2013: THE EVENTS SUDDEN UNILATERAL VISUAL LOSS AND TOTAL EXTERNAL OPHTHALMOPLEGIA COMBINED WITH MULTIFOCAL BRAIN INFARCTION, CENTRAL RETINAL ARTERY OCCLUSION, SKIN NECROSIS, EXOTROPIA, DIZZINESS AND WEAKNESS ASSESSED AS SERIOUS AND POSSIBLY RELATED. ADDITIONAL INFO PMA / 510(K): P040024.

    Description of Event or Problem · 1

    THIS IS CASE IS A LITERATURE (J. KOREA OPTHALMOL SOC. 2013 JUNE; 54 (6): 971-976 A CASE OF VISUAL LOSS AND OPHTHALMOPLEGIA FOLLOWING INJECTION OF HYALURONIC ACID INTO THE GLABELLA). WHICH REFERS TO A (B)(6) YEAR OLD, FEMALE. TO REPORT A CASE OF SUDDEN UNILATERAL VISUAL LOSS AND TOTAL EXTERNAL OPHTHALMOPLEGIA COMBINED WITH MULTIFOCAL BRAIN INFARCTION FOLLOWING INJECTION OF RESTYLANE (HYALURONIC ACID) INTO THE GLABELLA AREA. THE FEMALE PATIENT WAS INJECTED RESTYLANE (HYALURONIC ACID) FOR 5 TIMES INTO THE GLABELLA AREA. DURING THAT INJECTION, SHE FELT DIZZINESS AND WEAKNESS OF THE BODY, SO A DOCTOR INJECTED HYALURONIDASE ON THE GLABELLA SITE. AFTER THE INJECTION, SHE WAS REFERRED FOR SUDDEN UNILATERAL VISUAL LOSS AND BLEPHAROPTOSIS. VISUAL ACUITY WAS NO LIGHT PERCEPTION IN THE RIGHT EYE AND 0.15 IN THE LEFT EYE. SHE SHOWED BLEPHAROPTOSIS AND TOTAL EXTERNAL OPHTHALMOPLEGIA ON THE RIGHT SIDE. FURTHER EXAMINATION REVEALED CENTRAL RETINAL ARTERY OCCLUSION IN RT EYE. SHE HAD DEVELOPED SKIN NECROSIS AND A SURROUNDING REDDISH RETICULAR PATTERN ON THE FACE AROUND THE GLABELLA. BRAIN MRI SHOWED MULTIFOCAL PUNCTUATE ACUTE INFARCTION IN BOTH FRONTAL LOBES. SHE WAS HOSPITALIZED, AND GOT ORAL MEDICATION (ASPIRIN), IV TREATMENT (METHPREDNISOLONE 1G 3 DAYS), APPLYING ANTI-BIOTIC OINTMENT, WET DRESSING, AND MASSAGE OF EYE. AFTER 2 MONTHS, OPHTHALMOPLEGIA IMPROVED PARTIALLY ALTHOUGH HER RIGHT EYE VISION DID NOT, AND 15PD RIGHT EXOTROPIA WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319979 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| S 00567501