Belotero Balance (+) Lidocaine 8705M0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640123791138), received between Apr 12, 2022 and Apr 19, 2023 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH BELOTERO BALANCE LIDOCAINE US, INTO THE LIP LINES (OFF LABEL USE OF DEVICE). BATCH NUMBER WAS REPORTED AS 326141 (EXPIRY DATE: 09/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR BELOTERO BALANCE LIDOCAINE US WAS CONFIRMED AS 326141 (EXPIRY DATE: 09/2023). AFTER THE BELOTERO BALANCE LIDOCAINE US INJECTION, THE PATIENT EXPERIENCED A NODULE. THE HEALTH CARE PROFESSIONAL WAS SUSPICIOUS OF A VASCULAR OCCLUSION AND DISSOLVED IT WITH A HYALURONIC ACID (HA) ANTIDOTE. THE OUTCOME OF THE EVENTS WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16769795 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2022-00048 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH BELOTERO BALANCE LIDOCAINE US, INTO THE TEAR TROUGH (OFF LABEL USE OF DEVICE), AROUND 3 WEEKS PRIOR TO THIS REPORT, IN 2022. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR BELOTERO BALANCE LIDOCAINE US WAS CONFIRMED AS 326082 (EXPIRY DATE: 08/2022). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. IN 2022, AROUND 3 WEEKS AFTER THE BELOTERO BALANCE LIDOCAINE US INJECTION, THE PATIENT WAS STILL REALLY SWOLLEN. CORRECTIVE TREATMENT WAS TRIED AND INCLUDED ANTIHISTAMINES, ORAL STEROIDS, ICE AND LYMPHATIC DRAINAGE. THE REPORTER WAS THINKING THAT SHE GOT THE RIGHT EYE IN THE WRONG COMPARTMENT. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. FOLLOW-UP INFORMATION WAS RECEIVED ON 01-APR-2022: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT CREPEY SKIN WAS ADDED. THE EVENT TERM WAS STILL REALLY SWOLLEN WAS CHANGED TO WAS STILL REALLY SWOLLEN/ UNDEREYE SWELLING/ MALAR EDEMA, AND IT WAS RECODED FROM INJECTION SITE SWELLING TO INJECTION SITE EDEMA. TH

  Patient problems: Wrinkling

  MAUDE report 14087693 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2022-00049 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH BELOTERO BALANCE LIDOCAINE US, INTO THE TEAR TROUGH (OFF LABEL USE OF DEVICE), AROUND 3 WEEKS PRIOR TO THIS REPORT, IN 2022. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR BELOTERO BALANCE LIDOCAINE US WAS CONFIRMED AS 326082 (EXPIRY DATE: 08/2022). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. IN 2022, AROUND 3 WEEKS AFTER THE BELOTERO BALANCE LIDOCAINE US INJECTION, THE PATIENT WAS STILL REALLY SWOLLEN. CORRECTIVE TREATMENT WAS TRIED AND INCLUDED ANTIHISTAMINES, ORAL STEROIDS, ICE AND LYMPHATIC DRAINAGE. THE REPORTER WAS THINKING THAT SHE GOT THE RIGHT EYE IN THE WRONG COMPARTMENT. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. FOLLOW-UP INFORMATION WAS RECEIVED ON 01-APR-2022: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT CREPEY SKIN WAS ADDED. THE EVENT TERM WAS STILL REALLY SWOLLEN WAS CHANGED TO WAS STILL REALLY SWOLLEN/ UNDER EYE SWELLING/ MALAR EDEMA, AND IT WAS RECODED FROM INJECTION SITE SWELLING TO INJECTION SITE EDEMA. T

  Patient problems: Swelling/ Edema

  MAUDE report 14086626 ↗