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 Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, blurred vision (vision blurred), 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.The device history record could not be reviewed as the lot number was not reported.Literature citation: thulesen, j.& storm, m.C.(2021).Iatrogenic loss of vision by aesthetic treatment with filler.The journal of the danish medical association, 183:v09200639, 1-4.

Event Description

This mdr is related to mdr 3013840437-2021-00045, 3013840437-2021-00046, and 3013840437-2021-00048 referring to the same patient.This is a literature report presenting a treatment and handling algorithm based on casuistic data for emergency use in catastrophic situation.This literature report from denmark concerns a patient.The patient was injected with hyaluronic acid, as a facial aesthetic treatment.After the treatment with hyaluronic acid the patient experienced vascular compromise with visual loss (considered as permanent damage), also described as severe complications.The outcome of the events was unknown.In the opinion of the authors, prompt and sufficient action for vascular compromise with visual loss was essential.Follow-up information was received on (b)(6) 2021: new events blurred vision, blepharoptosis (mild) and diplopia were added.The patients age and gender were provided.The patient was a (b)(6) old female patient.She was injected with hyaluronic acid, under both eyes, for the reduction of circles under the eyes.Within two hours after the treatment with hyaluronic acid, the patient experienced right-sided ocular pain, cutaneous edema and discoloration.Through contact to the attending cosmetic clinic by telephone, she was advised to take antihistamines, apply cold compresses and wait and see.After a few hours of subjective deterioration, during which blurred vision, diplopia and cutaneous eruptions occurred, she visited an emergency ward.While waiting, she published an account of her subjective discomfort and photos of her face on social media.Qua feedback to instead find a cosmetic clinic for targeted and acute treatment, she consulted another cosmetic clinic, where due to symptoms and objective findings, including livedo reticularis-like skin rash with pustules, hyaluronidase (1200 units) was administered via a subcutaneous injection in the area treated with filler, on suspicion of arterial embolism.In addition, she was given acetylsalicylic acid and urgently referred to an eye clinic.In objective terms, right-sided blepharoptosis (also reported as mild), as well as a marbled hyperemic skin reaction in the periocular area was found, and in supply areas for the aa.Angularis, dorsalis nasi and supratrochlearis (as reported).In ophthalmological terms, inapparent conditions such as visual acuity, pupillary responses, motility and field of vision were found.Peroral endoscopic myotomy with prednisolone and moxifloxacin was initiated, while treatment with acetylsalicylic acid was continued, in combination with regular consultations, including orthoptic examinations ending after four months, where mild right-sided cutaneous hyperemia in the periocular area, including nasojugal sulcus was found.Conditions were otherwise normal.Due to the provided information, the outcome of the event vascular compromise was considered as and changed from unknown to resolving.Due to the provided information, the outcome of the event visual loss was considered as and changed from unknown to resolved.Due to the provided information, the outcome of the events blurred vision, blepharoptosis (mild) and diplopia was considered as resolved.In the opinion of the authors, the filler product had the possibility to be accidentally injected into an artery, where it migrated to the bloodstream in a retrograde fashion based on the infusion pressure from the treatment providers syringe.When the infusion pressure decreased, the intravascular filler product migrated with the blood in an antegrade fashion until there was an actual embolization in the smallest blood vessels/capillaries, which in the worst case were in a.Centralis retinae.The subjective symptoms typically occurred momentarily and depended on the physical localization of the ischaemic conditions.The symptoms had to lead to a prompt response, preferably within 60-90 minutes of the onset to be effective.When vision loss was diagnosed, the highest priority appeared to be retrobulbar injection of hyaluronidase in large doses (500-1500 units).It was better if the treatment was supplemented with the reduction of intraocular pressure by ocular massage and tension-reducing eye drops to reduce intraocular perfusion resistance.

Event Description

This mdr is related to mdr 3013840437-2021-00045, 3013840437-2021-00046, and 3013840437-2021-00048 referring to the same patient.Follow-up information was received on 13-mar-2021: the patient was initially treated in another clinic and was given a hyaluronic acid filler containing lidocaine.The reporter confirmed it was not a product from merz.

• 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
• MDR Report Key: 11486093
• MDR Text Key: 250644544
• Report Number: 3013840437-2021-00047
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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: Health Professional
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/13/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR