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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLBELLA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Loss of Vision (2139); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Article citation: clague, mike and goodman, greg. "a rethink on hyaluronidase injection, intraarterial injection, and blindness: is there another option for treatment of retinal artery embolism caused by intraarterial injection of hyaluronic acid?. " dermatological surgery, april 2016; pgs 547-549. The author has declined to provide further information regarding event, product, or patient details. The events of vascular occlusion, embolism, vision loss, and visual disturbances are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for the events. These are known potential adverse events addressed in the product labeling.
 
Event Description
The article "a rethink on hyaluronidase injection, intraarterial injection, and blindness: is there another option for treatment of retinal artery embolism caused by intraarterial injection of hyaluronic acid?" noted a healthcare professional injected a patient with juvéderm® voluma® with lidocaine in the temples and juvéderm® volbella® with lidocaine in the brow. Soon after the patient's injection in the right lateral brow with the juvéderm® volbella® with lidocaine, patient noted a "flashing sensation in [their] right eye and partial loss of vision. " injecting hcp injected hyaluronidase "widely into the brow and forehead area where there seemed to be swelling contemporaneously with the visual changes. Widespread hyaluroniodase in this area did not make any change to the visual symptoms. However, the practitioner then injected approximately 0. 8 ml (300 units) of hyaluronidase twice in short succession into the area of the supratrochlear and supraorbital notches with the second injection bringing instant relief of visual symptoms and return of eyesight.
 
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Brand NameUNK VOLBELLA
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 Key13713239
MDR Text Key286881445
Report Number3005113652-2022-00141
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 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK VOLBELLA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2022
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: 03/09/2022 Patient Sequence Number: 1
Treatment
JUVÉDERM® VOLUMA® WITH LIDOCAINE
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