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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUMA XC/LIDO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 12/22/2021
Event Type  Injury  
Event Description
Healthcare professional reported a patient was injected with juvéderm® voluma¿ xc in the lower eyelid and lateral cheek junction in the zygomatic region. Approximately eight months after the injection, patient presented to the office for evaluation of a painless, right lower eyelid mass that was present for 6 months. Examination revealed a "right lower eyelid, palpable, painless, well-circumscribed, mobile mass that appeared posterior to the orbital septum. [their] visual acuity was 20/20 in the right eye with normal pupillary function, full extraocular motility, and unremarkable hertel exophthalmometry and optic nerve function. " patient underwent a successful anterior orbitotomy through a transconjunctival incision that revealed a cystic encapsulated lesion. The lesion was sent for histologic analysis, which showed acellular grey-blue material surrounded by multinucleate foreign body giant cells consistent with hyaluronic acid-based filler. It was reported the "filler had migrated across the orbital septum". The patient was seen at two-week, six-week, and three-month postop appointments without any complications and full resolution of symptoms.
 
Manufacturer Narrative
The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Article citation: dryden, stephen et al. "a case of orbital granuloma secondary to dermal filler injection", cureus, 13(12), doi: 10. 7759/cureus. 20606. Further information regarding event, product, and patient details has been requested from corresponding author. 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. This is a known potential adverse event addressed in the product labeling.
 
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Brand NameJUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key13572164
MDR Text Key286337858
Report Number3005113652-2022-00099
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA XC/LIDO
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/21/2022 Patient Sequence Number: 1
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