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 Visual Impairment (2138); Foreign Body Embolism (4439)

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of vascular occlusion and vision abnormalities are a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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

Health professional reported injecting a patient in the tear trough with juvéderm® volbella¿ with lidocaine.After injecting the right side, the patient reported that they ¿couldn¿t see properly¿ on the right eye.The injector immediately stopped and pressed down hard on the area between the medial canthus of the eye and lateral of the nose, ¿occluding¿ the artery and vein.This was held for 5-10 minutes and the ¿blindness¿ subsided.The injector suspected that ¿filler was sucked into the artery.¿.

• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX ; 7372473605
• MDR Report Key: 11555152
• MDR Text Key: 241803967
• Report Number: 3005113652-2021-00189
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: 02/24/2021
• 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
• Patient Outcome(s): Other; Required Intervention