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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 Ischemia (1942); Loss of Vision (2139); Obstruction/Occlusion (2422)
Event Date 09/04/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Article citation: danks, jennifer j. , et al. ¿cosmetic filler blindness: recovery after repeated hyaluronidase injections. ¿ aesthetic surgery journal, vol. 42, no. 4, 2021, pp. 411¿16. Crossref, https://doi. Org/10. 1093/asj/sjab334. Further information regarding event, product, or patient details will be 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. 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 reported a patient had ipsilateral nasal injection via nasal tip with 0. 15ml juvéderm® voluma® with lidocaine. Immediately after injection, patient developed total loss of perception of light with afferent pupil defect, central retinal artery occlusion, cerebral irritation, and fundoscopy showing a cherry red spot. An mri was performed that showed ischemia. 675 international units (iu) of hyaluronidase was given immediately to the injection site and extra-orbital area. Within 4 hours, 3000 iu intra-orbital and 1500 iu extra-orbital hyaluronidase were given. One day later, patient's visual acuity recovered to 6/18. One month later, visual acuity improved to 6/6. Events resolved.
 
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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 Key14855693
MDR Text Key295124313
Report Number3005113652-2022-00400
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 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
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 Received06/17/2022
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: 06/29/2022 Patient Sequence Number: 1
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