MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE LYFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number UNKNOWN

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

Patient Problems Corneal Edema (1791); Eye Injury (1845); Ischemia (1942); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Viral Infection (2248); Discomfort (2330); Embolism/Embolus (4438); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of visual impairment, embolism and unexpected events of ulcerative keratitis, anterior segment ischaemia were considered possibly related to the treatments.Serious criteria include the need for multiple medical interventions.The non-serious expected events of pain, haemorrhage at implant site, discomfort at injection site, (b)(6) virus infection and unexpected events of ocular hyperaemia, eye irritation, eyelid oedema, swelling, corneal oedema were considered possibly related to the treatments.Potential etiologies include tiny embolus of filler lodged in a portion of the angular artery to dorsal nasal artery and partially occluded opthalmic vessel, leading to a low grade ocular ischemia and the delayed onset of skin findings and pain.Potential contributory factors include diffusion of filler particles into the anterior chamber after initial hyaluronidase dissolution therapy leading to toxic anterior segment syndrome that may have contributed to the acute and severe corneal edema.The glabella is a high risk area due to highly vascularized anatomy and proximity to the retinal arterial circulation.The restylane silk was used off label.The case meets the criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturer comment: lot number was not reported.

Event Description

Case reference number (b)(4) is a literature report identified on 19-aug-2020 during literature search.This case refers to a 60-year-old caucasian female patient.This case was identified from the literature article worley n, lupo m, holcomb k, kullman g, elahi e, elison j.Hyperbaric oxygen treatment of keratitis following facial hyaluronic acid injection.Ochsner-j 2020;20(2):193-196.Http://doi.Org/10.31486/toj.18.0133.We present the case of an unusual keratitis following facial ha injection that was successfully managed with the use of hyperbaric oxygen treatment (hbot).A 60-year-old caucasian female with no significant medical history received 2 ha injections (a restylane silk injection and a restylane lyft injection, galderma laboratories, lp) in the horizontal nasal crease, maxilla, and nasolabial folds.She had received ha injections in the same facial areas without complication 9 months earlier.Two days after the injections, she was treated for ecchymosis with a 532 nm laser.The next day, she experienced pain in the left nasolabial fold and left eye and reported blurred vision in the left eye.She presented to the emergency department; an optometrist diagnosed her with keratitis and started her on erythromycin ointment twice daily in the affected eye.The following day, the patient returned to the dermatologist's office and reported increasing pain in the left cheek and worsening redness, irritation, and continued vision loss in the left eye.She described severe pressure and pain on the left nasal crease extending up the left side of the nose and to the globe of the eye.She had a 1 cm reticulate patch and a firm nonvisible 3.5 x 1.5 cm area of swelling on palpation in the glabellar region.She was treated with 450 units of hyaluronidase (hylenex, halozyme therapeutics, inc.) to the nasolabial fold, the left side of the nose, and the glabella.She was also given aspirin 81 mg and ibuprofen 800 mg.She reported an 80% improvement in the pressure and pain within 15 minutes after administration of the hyaluronidase.She was instructed to apply 2% nitroglycerine ointment to the affected areas and was referred to an ophthalmologist for the evaluation of her decline in vision.The patient had an ocular history of dry eye, for which she had been using cyclosporine until the day of the injections.She had no history of contact lens use, herpetic eye disease, or recent rashes.Ocular medication was erythromycin ointment that she had started one day prior.Snellen visual acuity with correction was 20/25 in the right eye and 20/125 in the left eye and 20/40 with pinhole.Right eye examination and pressures were within normal limits.Examination of the left eye revealed no afferent pupillary defect, full extraocular movements and confrontational fields, 1+ left upper lid edema, 2+ conjunctival injection, intraocular pressure of 20 mmhg, and stromal opacity (keratitis) nasally with punctate fluorescein staining.The anterior chamber showed no cells and trace flare, but regularly shaped globules suspended in the aqueous were present.Retinal examination was within normal limits, and fluorescein angiography showed full vascular filling with a hazy view because of media opacity.The patient was advised to start ofloxacin antibiotic drops 4 times daily, continue erythromycin, and start cyclopentolate for discomfort.Twelve hours later, the patient reported a dramatic decrease in her vision.Visual acuity with correction in the left eye was 20/200 with no improvement on pinhole testing.She had generalized 2+ corneal edema, sparing a small area of the temporal cornea.The anterior chamber clear globules were no longer visible, and the keratitis appeared unchanged with persistent punctate staining of the epithelium.The view of the fundus was hazier, but the retina and the retinal vasculature appeared normal, and intraocular pressure was in the normal range.The patient was treated with 75 units of hyaluronidase to the inferior periocular region and 75 units to the glabella and left nasal sidewall (150 units total).Because of her acute vision deterioration, she was referred for emergent hbot for possible anterior segment ischemia and keratitis.The patient underwent nine 90-minute hbots and stated that her vision began to improve within 20 minutes of the first session.Her visual acuity measured by near card in the hyperbaric facility improved from 20/200 at the start of treatment to 20/60 at the 20th minute.On day 2 of her hbot, the patient's visual acuity was 20/60, and intraocular pressure was 12 mmhg.Corneal edema and keratitis were significantly decreased; the area of stippled staining was smaller, approximately 2 x 1.5 mm; the anterior chamber was clear; and the fundoscopic examination was normal.On day 3, the patient stated that her vision fluctuated but was gradually improving overall.She perceived that her vision improved during and immediately after each hbot but that the effects of each treatment had decreased by the time she had the next session.Visual acuity was 20/200 in the left eye and 20/60 with pinhole.The keratitis was nearly resolved, but a corneal infiltrate measured 1.5 x 1.5 mm.The patient was started on fortified vancomycin 25 mg/ml and tobramycin 15 mg/ml drops 4 times daily, genteal ointment (novartis pharmaceuticals corp.) every night, and valacyclovir (valtrex) 500 mg 3 times daily to account for the possibility of an atypical herpetic component.She continued to improve with each 90-minute hbot.On day 10, her vision was 20/20, and the infiltrate had nearly resolved.A small stromal scar, approximately 1 mm in diameter, corresponded to the site of the ulcer in the nasal cornea.One month later, the patient reported that her vision had returned to baseline.Her visual acuity with correction was 20/20.The cornea was clear, and her eye examination was normal.Ours is the first case of anterior segment and corneal pathology following facial ha injection that resolved with hbot.The unusual and aggressive keratitis that occurred in our patient after facial ha injection responded quickly to hbot, suggesting a reversible ischemic process.The keratitis occurred on the same side as the facial pain ecchymosis and skin reticulation post ha injection, indicating a likely association between the ocular findings and the injection.We hypothesize the presence of emboli causing low-grade ocular ischemia that could have led to the keratitis and corneal edema.When the hyaluronidase was injected, the plug was dissolved and may have diffused into the anterior chamber, possibly causing a toxic anterior segment syndrome that may have contributed to the acute and severe corneal edema the patient experienced the following morning.This patient had rapid improvement with each treatment that was partially sustained until her next session.While we would expect an ischemic injury to the cornea to take many hours or days to heal, even with hbot, our patient had marked improvement in minutes.Sustained improvement, however, took more than a week.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10504422
• MDR Text Key: 214817075
• Report Number: 1000118068-2020-00033
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2020
• Distributor Facility Aware Date: 08/19/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR