MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number GBF0508

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient reports she's having vision issues and was told by an ophthalmologist that it was bellafill that was injected in 2017, that has travelled from her nasolabial folds to under her eyes.As of the date of this report, the patient has not allowed contact with the ophthalmologist.On 4/23/21: the patient left a message stating she believes her product travelled to another area after injection.On 4/30/21: suneva spoke with the patient.She states she was injected by (b)(6) at (b)(6) in the nasolabial folds (nlf).The patient says she was told the product broke off and travelled to the top of her cheeks below her eyes.She says she can feel it up there.We discussed how studies show the product does not travel once it is placed and once placed as directed there is no means for the product to migrate.She says that she's having vision issues and saw an ophthalmologist who did an mri and it was the ophthalmologist who believes it is the bellafill that has broken off from the original injection location and has travelled.She states she is healthy and has no other issues.She says it's okay for suneva to follow up with her injector to get more info about her bellafill injections.She will call back next week with the ophthalmologist's contact info.On 5/5/21: suneva spoke with the injecting account, (b)(6).The patient was injected in the "mid-face" on (b)(6) 2017, with lots f161068 and f161091.They will have the injector ((b)(6), aprn) call with exact injection locations.On 5/5/21: suneva spoke with the injector: she relays that she didn't put the product under the patient's eyes.She only injected a little bit in the mid face and the nlf.The furthest up they injected was under the zygomatic arch area, but nowhere near the "obiculous" area (muscle around the eyes).She also states, based on where she injected the product, there would be no way for it to affect the patient's vision unless the artery was involved.However, if that had occurred, the patient would have had immediate vision issues at time of injection, not after 4 years.On 5/19/21: no info provided from patient yet re: ophthalmologist contact info.Suneva left a message for the patient.On 5/20/21: no response from the patient.Suneva left another message asking about ophthalmologist contact info.On 5/21/21: no response from patient.Suneva called again and spoke with the patient.She hasn't had a chance to call dr.(b)(6).She's been very busy.Per the patient, dr.(b)(6) is the opth/derm that she's been seeing.She wants suneva to wait to call the doctor till next week after she lets the doctor know to expect our call.She won't provide the doctor's contact info to suneva until after that.Date of the event: the date of event is unknown, but is suspected to have occurred recently in 2021.Device lot number and manufacture date: there were two (2) lots used in the patient's bellafill procedure: lot f161068, udi: (b)(4), expiration date: 10/20/2017, manufacture date: 05/27/2016.Lot f161091, udi: (b)(4), expiration date: 11/24/2017, manufacture date: 07/12/2016.Both lot numbers used in the patient's bellafill procedure were evaluated and no issues were noted in manufacturing records.The lots have since expired; therefore, retained samples were not available for review.There are no prior reports of vision issues or migration with either lot.The suspected root cause of the patient's reported vision issues is unknown at this time due to insufficient information; however studies have shown that the bellafill dermal filler does not migrate once implanted.In addition, the injecting account relays that she did not inject in an area that would affect the patient's vision.The furthest up they injected was the zygomatic ar area and nowhere near the area around the patient's eyes.Per the bellafill instructions for use (ifu): bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.Bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".

Event Description

Patient reports she's having vision issues and was told by an ophthalmologist that it was bellafill that was injected in 2017, that has travelled from her nasolabial folds to under her eyes.As of the date of this report, the patient has not allowed contact with the ophthalmologist.

• Brand Name: BELLAFILL DERMAL FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer Contact: stacy lewis ; 5870 pacific center blvd.; san diego, CA 92121 ; 8587685492
• MDR Report Key: 11867530
• MDR Text Key: 263578326
• Report Number: 3003707320-2021-00005
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2017
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F161068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability