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U.S. Department of Health and Human Services

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

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ANTEIS S.A. BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, superior subconjunctival hemorrhage (conjunctival hemorrhage), was deemed to meet serious injury criteria of resulted in 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. Literature citation: eldweik, l. (2021). Orbital infarction syndrome following hyaluronic acid filler rhinoplasty. American journal of ophthalmology.
 
Event Description
This mdr is related to mdr 3013840437-2021-00091, 3013840437-2021-00092, 3013840437-2021-00093, 3013840437-2021-00094, and 3013840437-2021-00096 referring to the same patient. This literature report from (b)(6) concerns a (b)(6) female patient. She was injected with a total of 0. 5 ml of hyaluronic acid, over the nasal bridge (intentional device misuse), for a non-surgical filler rhinoplasty to correct a nasal hump deformity. A 30-gauge needle was used. The patient was healthy. Immediately after the treatment with hyaluronic acid, the patient experienced a complete loss of vison in her left eye, further described as unilateral acute blindness. While still at the doctors office, she received hyaluronidase enzyme injections subcutaneously (40 units/cm2) in the area over the nose and around the left eye. However, a firm swelling with tenderness around the left eye started to develop. The patient rushed to the emergency department with worsening persistent dull, aching pain, and bluish discoloration of the facial skin. She was evaluated by an ophthalmologist on-call within less than one hour. Her visual acuity was no light perception in the left eye. The left globe was frozen with hypotropia, exotropia, and complete external ophthalmoplegia with blepharoptosis. There was necrotic tissue on both sides of the nose, and the left forehead. Slit lamp biomicroscopy of the left eye showed conjunctival chemosis, superior subconjunctival hemorrhage and grade 4 corneal haze obscuring other intraocular structures. She was diagnosed with acute left orbital infarction secondary to hyaluronic acid filler injection. Then, an immediate peribulbar injection of 2 ml (total of 300 units) of hyaluronidase enzyme was given followed by vigorous massage aiming to disburse the bulk of the filler material. However, no improvement in vision was noted. A three-dimensional computed tomography angiogram (3d-cta) of the head and neck showed patent arterial vasculature. A computed tomography (ct) of the head and the orbits showed normal brain parenchyma without focal lesion. The patient received intravenous methylprednisolone, 1 gm daily for 5 days, in addition to broad spectrum antibiotic coverage, antibiotic creams, and oral aspirin. As reported, systemic steroids were also given. After 8 weeks from presentation, her visual acuity did not change. The skin necrosis resolved with residual scarring. Left extraocular movement and blepharoptosis improved. There was near full ocular motility with mild residual limitation of elevation in the left eye. It was also reported that eight weeks later, the extraocular motility fully recovered. The consequences of ischemia on the anterior and posterior ocular segments persisted. Slit lamp biomicroscope revealed clear cornea, with a dilated pupil and iris atrophy. Fundus exam indicated severe ischemia of the optic nerve and retina. There were fibrovascular membrane formation over the optic disc, intra-arterial emboli visible along the superior temporal retinal artery and diffuse retinal ischemia with pigmentary changes. Optical coherence tomography demonstrated diffuse retinal thinning of the inferior macula. There was loss of normal architecture of the retina due to severe ischemia involving the inner and outer retina. As reported, this treatment was unable to substantially recanalize retinal artery occlusion for the patient. The outcome of the event skin necrosis was reported as resolved with sequelae. Due to the provided information the outcome of the event ophthalmoplegia was considered as resolving. Due to the provide information, the outcome of the events retinal artery occlusion, left orbital infarction/ anterior and posterior segment ischemia and complete loss of vison was considered as not resolved. The outcome of the events superior subconjunctival hemorrhage and iris atrophy was unknown. In the opinion of the author, during injecting, the filler possibly reverses the flow in the lateral nasal artery and then travel through the ophthalmic artery just proximal to the origin of the retinal artery. As these were considered small arteries, it did not take a large volume of filler to occlude the retinal circulation and induce permanent ischemia. The patient received subcutaneous and peribulbar hyaluronidase within the proposed window of treatment before the development of irreversible retinal damage. However, the treatment was unable to substantially recanalize retinal artery occlusion for the patient. The visual effects of arterial occlusion were devastating and irreversible. The report did not rule out the probability that patients who receive peribulbar hyaluronidase within four hours after filler injection can benefit from the treatment.
 
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Brand NameBELOTERO BALANCE
Type of DeviceIMPLANT, 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 rd
raleigh, NC 27615
9195828000
MDR Report Key11678212
MDR Text Key261836048
Report Number3013840437-2021-00095
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
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