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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Loss of Vision (2139); Obstruction/Occlusion (2422)
Event Date 09/04/2021
Event Type  Injury  
Manufacturer Narrative
Article citation: danks, jennifer j. , et al. ¿cosmetic filler blindness: recovery after repeated hyaluronidase injections. ¿ aesthetic surgery journal, 2021. Crossref, doi:10. 1093/asj/sjab334. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Through the article, "cosmetic filler blindness: recovery after repeated hyaluronidase injections," it was noted a patient was injected with 0. 15ml juvéderm® voluma® with lidocaine into the right side of nose via 25-gauge cannula from the nasal tip, superior to the meidal canthus. Immediately following injection, there was pallor of the skin and hyalase® was prepared. Patient reported feeling odd around the right eye. Patient suffered complete sudden right visual loss with right side headache. Patient was treated with 675 iu of hyaluronidase at the filler site. Approximately an hour and half post injection, patient was admitted to emergency department. There was ¿mottling of skin of the right forehead, glabella and nose¿. Hcp noted ¿right visual acuity (va) was npl, there was a right afferent pupil defect (apd)¿. Patient had normal extra ocular movements, anterior segment was normal, intraocular pressure were 4mmhg right and 11mmhg and the right fundus was revealed to have a cherry red spot at the fovea with retinal pallor. Opthalmolist confirmed diagnosis of right central artery retinal artery occlusion. Patient was agitated and iv sedation was utilized. Ct showed no cerebral ischemia, hemorrhage or aneurysm. Approximately four hours post injection, apd persisted, but va improved to count fingers. Patient was treated with three additional injections of 1500 iu hyaluronidase. The discomfort of the subcutaneous injection required further sedation. Patient was given a ¿loading dose¿ of aspirin¿. About four and half hours later, patient was reexamined. There was resolution of the cherry red spot with improved perfusion of the retina. The following day, va had improved to 6/18 and left va to 6/6. There was no apd. Ocular coherence test (oct) revealed thickening of the inner retinal layers at the fovea and adjacent to the fovea. Oct angiography revealed drop out of the inferior superficial capillary layer. Mri revealed changes consistent with small scattered areas of acute ischemia in the anterior circulation. Patient was discharged and was prescribed aspirin. Va improved to 6/6 at one month. Hcp noted, "recovery of vision was remarkable, from npl to 6/6, documented at a tertiary referral eye hospital. Humphrey visual field 24-2 showed partial loss of the right superior visual field corresponding to an area of atrophy of the inner retinal capillary network, inferior to the fovea, demonstrated on oct angiography imaging. " aspirin was ceased.
 
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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 Key13337883
MDR Text Key284840599
Report Number3005113652-2022-00046
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA XC/LIDO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/24/2022 Patient Sequence Number: 1
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