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

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.

• Brand Name: UNK VOLBELLA
• Type of Device: IMPLANT, 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 Key: 13713239
• MDR Text Key: 286881445
• Report Number: 3005113652-2022-00141
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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 Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA® WITH LIDOCAINE
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female