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, ophthalmic artery occlusion, was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Citation: kim, b.J., you, h.J., jung, i., & kim, d.W.(accepted/in press).Ophthalmoplegia with skin necrosis after a hyaluronic acid filler injection.Journal of cosmetic dermatology.Https://doi.Org/10.1111/jocd.13403.

Event Description

This case is related to 3013840437-2020-00052, 3013840437-2020-00054, and 3013840437-2020-00055.This literature report from the republic of korea concerns a (b)(6) female patient.She was injected with hyaluronic acid into the nasal dorsum, at a local clinic.Twenty-four minutes after the hyaluronic acid injection, the patient experienced dizziness, headache, horizontal diplopia, oculodynia, blurred vision, and right eye lateral deviation.Hyaluronidase was injected immediately.One hour after the hyaluronic acid injection the patient went to the emergency center of the hospital.Hypertropia and exotropia of the right eye were observed.Blurred vision and diplopia were improved at initial presentation.Light pupillary response was normal, and relative afferent pupillary defect was not observed.Extraocular muscle movement was assessed, showing limitation in adduction and depression.Elevation was also limited to a mild degree.Ocular pain was aggravated with movement.Purple skin discoloration was noted from the nasal alae to the lower half of the central forehead.She had a fever of 37.8°c, which subsided after receiving antipyretics.Fundus photography showed mild intorsion and no ischemic change in the right eye.T2-weighted magnetic resonance imaging (mri) of the orbit showed increased signal intensity of the medial rectus and inferior rectus, suggesting acute infarction of the extraocular muscles.Brain diffusion-weighted mri and mr angiography findings were normal.However, residual hyaluronic acid was observed in the nasal dorsum.Approximately 24 hours after the filler injection, the patient received a subcutaneous injection of an additional 1500 iu of hyaluronidase, targeting the residual filler material observed on the mri and the area of color change.She received steroid pulse therapy using an intravenous methylprednisolone, 1000 mg daily, for 5 days, and oral prednisolone, 60 mg daily, tapered after 5 days.She also received 5700 iu of nadroparine, daily, an intravenous injection of 10 [?]g of prostaglandin e1, daily, 10 mg of nicergoline, daily, and an intravenous injection of ampicillin and sulbactam.The ischemic skin area was treated with a human epithelial growth factor ointment and hyaluronic acid gel.Three days after the filler injection, the visual field normalized and ptosis, diplopia, and eye movement limitations recovered.However, full-thickness necrosis was present in the glabellar skin area.Within 2 weeks of using the human epithelial growth factor ointment and hyaluronic acid gel, complete healing was achieved.The remaining scar and redness were treated using laser therapy.After completing 10 sessions of 1064 nm nd:yag laser treatment at 2-week intervals, the patient was satisfied with the residual minimal scar.Three years after the hyaluronic acid injection, all skin lesions and oculomotor nerve palsy had completely resolved without any ocular sequelae.In the opinion of the author, the patient had classical signs of vascular complication, with additional limitations of the extraocular muscle function and ptosis.Her right eye was deviated in a lateral, upward direction, with ptosis and intorsion, consistent with oculomotor nerve palsy involving both the superior and inferior division.Purple skin discoloration was observed from the nasal alae to the lower half of the central forehead and resulted in necrosis of the glabella area.These symptoms led the authors to suspect an ophthalmic artery occlusion, and thus, a treatment using hyaluronidase, low-molecular-weight heparin, and steroids was initiated.Although ophthalmoplegia has better prognosis than vision loss after ophthalmic artery occlusion, a detailed understanding of vascular anatomy and injection techniques not to injure the vessels is essential for the prevention of filler-related complications.

• 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: 10142652
• MDR Text Key: 201002629
• Report Number: 3013840437-2020-00053
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR