BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE VOLYME

    MDR report key: 23967629 · Received January 5, 2026

    Report

    Report Number
    9710154-2026-00001
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 6, 2025
    Report Date
    January 5, 2026
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P140029 S055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENTS OF RETINAL VASCULAR OCCLUSION, BLINDNESS TRANSIENT AND THE NON-SERIOUS EVENT OF EYE SWELLING WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND ITS MANIFESTATIONS. ALTERNATIVE ROOT CAUSE INCLUDES CONCOMITANT NON-GALDERMA UNSPECIFIED HA FILLER TREATMENT. RESTYLANE VOLYME IN THE EYEBROW AND RESTYLANE DEFYNE IN THE TEAR TROUGH WERE USED OFF-LABEL. SCULPTRA AND RESTYLANE DEFYNE WERE INTENTIONALLY MISUSED WITH REGARD TO CANNULA USE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. TO DATE, THIS IS THE ONLY MEDICAL COMPLAINT REPORTED FOR THE LOT NUMBER. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2025 BY AN OTHER HEALTH PROFESSIONAL VIA A SALES REPRESENTATIVE CONCERNING A FEMALE PATIENT OF AN UNKNOWN AGE. ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2025 FROM SAME REPORTER. NO INFORMATION ABOUT MEDICAL HISTORY, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2025, THE PATIENT RECEIVED TREATMENT WITH 2 ML OF RESTYLANE VOLYME (LOT 22916-1) TO EYEBROW PEAK, EYEBROW TAIL, TEMPLE AND ZYGOMATIC LIGAMENT USING PROVIDED NEEDLE WITH UNKNOWN INJECTION TECHNIQUE. ON THE SAME DAY, THE PATIENT RECEIVED TREATMENT WITH 0.4 ML OF RESTYLANE DEFYNE (LOT 23028-1) TO TEAR TROUGH USING 22G CANNULA WITH UNKNOWN INJECTION TECHNIQUE. ADDITIONALLY, THE PATIENT RECEIVED ALSO TREATMENT WITH 8 ML (2 VIALS) OF SCULPTRA (LOT 5J0721) TO THE HAIRLINE, IN FRONT OF THE EARS, NASOLABIAL FOLDS AND JAWLINE USING 22G CANNULA WITH UNKNOWN INJECTION TECHNIQUE. THE SCULPTRA WAS INJECTED USING 22G CANNULA/RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA (INTENTIONAL DEVICE MISUSE) AND RESTYLANE VOLYME WAS INJECTED TO EYEBROW PEAK, EYEBROW TAIL /RESTYLANE DEFYNE WAS INJECTED TO TEAR TROUGH (OFF LABEL USE OF DEVICE). CONCOMITANTLY, THE PATIENT ALSO RECEIVED TREATMENTS WITH INJECTION OF PAVE DERM J-FILL SOFT DERMAL FILLER USING A 22G CANNULA TO HAIRLINE AND PREAURICULAR AREA AND INJECTION OF NEURAMIS USING A 22G CANNULA TO NASOLABIAL FOLDS AND JAWLINE. ON THE SAME DAY AFTER THE TREATMENT, THE PATIENT EXPERIENCED LEFT EYE SWELLING (EYE SWELLING) WITH LEFT EYE VISION LOSS (BLINDNESS TRANSIENT). LATER, THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH SEVERE RETINAL VASCULAR OCCLUSION (RETINAL VASCULAR OCCLUSION), WHICH REQUIRED HOSPITALIZATION ON (B)(6) 2025. THE PATIENT WAS TREATED WITH HYPERBARIC OXYGEN THERAPY. THE PATIENT UNDERWENT UNSPECIFIED CATHETER-BASED IMAGING TWICE, BUT NO ABNORMALITIES WERE OBSERVED IN (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND SHE WAS BACK TO NORMAL LIFE. THE REPORTING HCP ASSESSED CAUSALITY TO THE TREATMENT WITH THE EVENT RETINAL VASCULAR OCCLUSION AS NOT ASSESSABLE. OUTCOME AT THE TIME OF THE REPORT: LEFT EYE SWELLING WAS RECOVERED/RESOLVED. LEFT EYE VISION LOSS WAS RECOVERED/RESOLVED. RETINAL VASCULAR OCCLUSION WAS RECOVERED/RESOLVED. SCULPTRA WAS INJECTED USING 22G CANNULA/RESTYLANE DEFYNE WAS INJECTED USING 22G CANNULA (INTENTIONAL DEVICE MISUSE). RESTYLANE VOLYME WAS INJECTED TO EYEBROW PEAK, EYEBROW TAIL /RESTYLANE DEFYNE WAS INJECTED TO TEAR TROUGH (OFF LABEL USE OF DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24430 RESTYLANE VOLYME IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB 22916-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R