MAUDE Adverse Event Report: ANTEIS S.A. BELOTERO BALANCE; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, left ophthalmic artery occlusion (vascular occlusion) was assessed as meeting the reporting criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.Citation: lee js, kim jy, jung c, woo sj.Iatrogenic ophthalmic artery occlusion and retinal artery occlusion.Progress in retinal and eye research.2020 mar:100848.Doi: 10.1016/j.Preteyeres.2020.100848.

Event Description

This case was linked to 3013840437-2020-00045, 3013840437-2020-00046, 3013840437-2020-00047, 3013840437-2020-00048 referring to the same literature article.This literature report from (b)(6) concerns a (b)(6) year-old female patient.She was treated with hyaluronic acid into the nose.After the treatment with hyaluronic acid, the patient experienced left ophthalmic artery occlusion.A wide fundus photograph obtained at the initial visit showed diffuse retinal oedema with "cherry-red spot" sign and multiple segmented retinal arteries.Retinal and choroidal perfusion was severely diminished in fluorescein angiography.Clinical photographs taken on the day of the event shows marked limitation of extraocular muscle movement and ptosis.Anterior segment photograph, obtained one day after the treatment, showed diffuse corneal oedema due to anterior segment ischemia.Anterior segment photograph obtained two months after the event showed that corneal oedema was resolved, but the iris seems to have atrophied and a cataract seems to have developed.The outcome of the events was not reported.In the opinion of the authors, iatrogenic ophthalmic artery occlusion is a rare but devastating ophthalmic disease that may cause sudden and permanent visual loss.Understanding the possible etiologic modalities and pathogenic mechanisms of iatrogenic ophthalmic artery occlusion may prevent its occurrence.Follow-up information was received on (b)(6) 2020: the reporter informed that he did not have the information of all the fillers commercial names, that had been used in this literature case.According to the reporter, after searching the list of fillers they reviewed, they were not able to find the company filler on the list.

• Brand Name: BELOTERO BALANCE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• Manufacturer (Section G): ANTEIS S.A.; 18, chemin des aulx; 1228 plan les ouates; geneva, ; SZ
• Manufacturer Contact: product safety ; 6501 six forks road; raleigh, nc ; 5828000
• MDR Report Key: 9974768
• MDR Text Key: 191820556
• Report Number: 3013840437-2020-00044
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR