MAUDE Adverse Event Report: Pringy Juvederm Voluma XC 27G 2 x 1mL; implant, dermal, for aesthetic use

Catalog Number	94640
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Subcutaneous Nodule (4548)
Date of Event	04/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported that a patient was injected with juvéderm® voluma¿ xc and the product migrated above the eye.Hcp had to utilize the ultrasound to dissolve the product.Additionally, the healthcare professional reported that the patient received juvéderm® voluma¿ xc in the right lateral cheek last year.The patient experienced mild swelling as an adverse event.One month later, filler was observed in the eyelid, and the issue persisted two months later.During a follow-up appointment, the hcp stated that the swelling had moved toward the eye and caused a bulging vein.The hcp made several attempts to dissolve the product; each attempt resulted in mild improvement but did not fully resolve the issue.Ultrasound imaging showed that the product had been placed in connective tissue and muscle.Diagnostic tests performed last year showed the following: the first ultrasound identified ha blocking in the deep temporal artery; the next ultrasound noted a filler nodule in the eyelid; and the final ultrasound identified a nodule on the right eyelid, with filler product located lateral to the right eye.The nodule was located on the right tarsal eyelid, and a large amount of filler product was present in the eye muscles.Ha blocking was also observed in the lateral orbital vein.Medical intervention was provided last year with hylenex under ultrasound guidance using a 27-gauge, 1.5-inch needle on three separate occasions.The patient¿s symptoms have not resolved, and the patient is scheduled for another follow-up appointment.
Event or Problem Description
Following an aesthetic injection complication, multiple in-person and telemedicine assessments and filler-dissolving treatments were completed.Treatment history included hyaluronic acid filler injections to the deep temple and lateral cheek, with prior filler placements in the cheeks, temples, and under-eye areas by other providers.Persistent concerns involve subtle right upper-eyelid fullness and a small superficial vein near the outer eye, although significant improvement and no visual disturbance, pain, swelling, skin changes, tearing, dryness, inflammation, or hypervascularity were reported.Examination identified soft, non-tender, non-red fullness visible only with upward eyelid traction; imaging associated the area with a herniated infraorbital fat pad and showed no filler.Laser treatment may be considered if the superficial vein remains cosmetically bothersome.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b5, b6, h8.

• Brand Name: Juvederm Voluma XC 27G 2 x 1mL
• Common Device Name: implant, dermal, for aesthetic use
• Manufacturer (Section D): Pringy; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): Pringy; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50789175
• Report Number: 3005113652-2026-01092
• Device Sequence Number: 13115682
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2026
• Device Catalogue Number: 94640
• Device Lot Number: 1002724365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female