RHA® 4 RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2 (REF 940083/03)Recalls & reported problems
Teoxane SA · "One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234371) is defined as unit of sales and identified with a serial number." · Class 3 · Implant
All models of RHA 4 (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640173234388), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Off-Label Use; Off-Label Use
WIDESPREAD SKIN CONDITION/ SYSTEMIC REACTION [SKIN REACTION] RH4 IN THE TEAR TROUGH CHEEKS LIPS [OFF LABEL USE] VISION LOSS TEMPORARILY/FUZZY VISION/FILM LIKE FEELING ON EYE/SPORADIC ¿FLARE UP¿ OF VISION AND A FOGGY FEELING EYE [VISUAL IMPAIRMENT] REDNESS [INJECTION SITE ERYTHEMA] PAIN/TENDER WHEN PRESSED [INJECTION SITE PAIN] TINGLING UNDEREYES [INJECTION SITE PARAESTHESIA] FEVER/INTENSE HEAT [INJECTION SITE WARMTH] HARD LUMP//UNEVEN UNDEREYE/DISFIGURED UNDEREYE/LUMPY [INJECTION SITE MASS] FULLNESS BENEATH LEFT ORBIT/OEDEMA/SWELLING, EYE WILL SWELL UP LIKE IT HAS MIGRATED [INJECTION SITE OEDEMA] HARD LUMP [INJECTION SITE INDURATION] CASE NARRATIVE: ON 09-JUN-2025, PRIMEVIGILANCE FROM USA NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. ACCORDING TO THE INFORMATION RECEIVED FROM THE CAREGIVER (NURSE) A FEMALE PATIENT WAS INJECTED ON (B)(6) 2025 WITH RHA 4 (1-2 SYRINGES) IN THE TEAR TROUGH, CHEEKS AND LIPS WITH A NEEDLE BY A PHYSICIAN. THE PATIENT HAD A HISTORY OF: - JUVEDERM VOLUMA INJECTION ON (B)(6) 2023 (UNKOWN INDICATION) - UNKOWN RHA PRODUCT INJECTION ON (B)(6) 2023 (UNKOWN INIDCATION) - ALLERGY TO ERYTHROMYCIN SINCE (B)(6) 1999, WHICH CAUSES VOMITING. ON AN UNSPECIFIED DATE, THE
Patient problems: Visual Disturbances
MAUDE report 23541998 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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