MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM-CONC/ADD

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

Patient Problems Loss of Vision (2139); Low Oxygen Saturation (2477); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 11/20/2017

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 event of ¿immediate blindness¿ is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling: warnings: ¿ the product must not be injected into blood vessels.Introduction of juvéderm® ultra xc into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.Take extra care when injecting soft-tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary.Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.Patients should receive prompt medical attention and possibly evaluation by an appropriate health care professional specialist should an intravascular injection occur (see health care professional instructions #13).Precautions: ¿ the safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds, lips, and perioral area have not been established in controlled clinical studies.Adverse events: the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma.In many cases, the symptoms resolved without any treatment.Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress.Vascular occlusion of vessels resulting in necrosis and vision abnormalities, have been reported following injection of juvéderm® products, with and without lidocaine, with a time to onset ranging from immediate to within one week following injection.These reported events likely resulted from inadvertent arterial injection.In many of these cases, the product was injected into the highly vascularized areas of the glabella, nose, and periorbital area.Reported treatments include: anticoagulants, epinephrine, aspirin, hyaluronidase, steroid treatment, eye drops, hyperbaric oxygen, and surgery.Outcomes have ranged from completely resolved to ongoing at the time of last contact.

Event Description

Healthcare professional reported after injection by an unknown physician in the ¿dorsal nasal¿ with unspecified juvéderm® the patient experienced ¿immediate blindness¿ in the right eye that occurred ¿5 seconds after the injection.¿ the patient is suffering from ¿ptosis of the right eye.¿ reporter went on to advise the ¿extra ocular muscles are affected, so eye ball is fixed and dilated¿ and the ¿right side of face felt cold around the orbit area.¿ the patient visited multiple emergency rooms in the days following the injection where they received ¿iv prednisone, iv antibiotics, & ct (scan)." the patient was referred to the reporter ¿a week after the injection.¿ six days after injection the patient was provided hyaluronidase.The symptoms are ongoing.

Manufacturer Narrative

Article citation: (b)(6) and ocular ischemic syndrome with blindness after facial filler injection.Ophthal plast reconstr surg, vol.Xx, no.Xx, 2018.(b)(4).

Event Description

Additional information: additional information provided from a literature article, orbital and ocular ischemic syndrome with blindness after facial filler injection, included the following: the patient was diagnosed with a central retinal artery occlusion by an ophthalmologist.Patient had a brain imaging which did not show any abnormalities.During admission, the patient also developed pustule skin lesions across their brow, nose and face.Patient was then given intravenous steroids and antibiotics with no improvements.Patient still had no light perception and developed pain in the eye 2 days after admission.7 days after the injection and vision loss the patient visited the clinic, it was noted that the patient had no light perception vision with dull retrobulbar ache, crusted lesions on the forehead and nose, edematous and photic eyelid, conjunctival injection and subconjunctival hemorrhage, and anterior chamber hypopyon with a fixed, dilated pupil.Orbital signs included motility impairment in all gazes and proptosis with moderate resistance to retropulsion.Intraocular pressure was 8mmhg on the right side compared to 18mmhg on the left.The writer diagnosed the patient with filler-related vascular occlusion involving the ophthalmic artery.Patient also had skin necrosis in the characteristic distribution, central retinal arterial occlusion, orbital ischemia manifesting with a 3rd cranial nerve palsy (ptosis, dilated pupil, and motility restriction) and orbital congestion (proptosis and resistance to retropulsion), and ocular ischemia manifesting as hypopyon and ocular hypotension).Patient was then treated with hyaluronidase diluted in normal saline and injected to the orbital apex and skin lesions.24 hours later, the patient described significant improvement in the orbital eye pain and improvement of ptosis.Two weeks later, the patient noted improvement in the ocular ischemia and resolution of the hypopyon and improved ptosis and ocular motility and improvement in the skin.The patient still had no light perception.

• Brand Name: JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7143480
• MDR Text Key: 95665132
• Report Number: 3005113652-2017-01732
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM-CONC/ADD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 23 YR