ClearCorrect System Aligner (Multi-layer) (REF REF03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI D865REF03001), received between Oct 9, 2023 and May 28, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Patient Device Interaction Problem

  THE PATIENT WAS USING STEP 1, PHASE 1 ALIGNERS FOR BOTH ARCHES. AFTER WEARING THE TRAYS FOR A FEW DAYS, THE SYMPTOMS REPORTEDLY WORSENED EACH DAY. THE PATIENT EXPERIENCED AN ALLERGIC-TYPE REACTION THAT INCLUDED RASH, SORES, SWELLING, VOMITING, VERTIGO, AND TINNITUS. THE CALLER WAS UNSURE WHETHER THE PATIENT HAD A FEVER. NO DIFFICULTY BREATHING WAS REPORTED. THE CALLER WAS UNSURE ABOUT ANY KNOWN ALLERGIES TO PLASTIC, AND NO ALLERGIES TO DISINFECTANTS WERE REPORTED. THE ALIGNERS WERE RINSED BEFORE SEATING AND CLEANED USING ONLY WATER. THE PRODUCT APPEARED CLEAN AT THE TIME OF THE REPORT. THE PATIENT WAS EVALUATED BY A PRIMARY CARE PHYSICIAN; HOWEVER, NO SPECIFIC DIAGNOSIS WAS PROVIDED. THE REPORTED SYMPTOMS INCLUDED VOMITING, VERTIGO, AND TINNITUS. TO ALLEVIATE THE REACTION, THE PATIENT WAS ADVISED TO DISCONTINUE ALIGNER USE. MEDICATIONS PRESCRIBED INCLUDED PREDNISONE AND MECLIZINE. PHOTOS OF THE CONDITION WERE REQUESTED, BUT NONE WERE AVAILABLE. THE PRODUCT IS AVAILABLE TO BE RETURNED IF NEEDED.

  Patient problems: Subclinical Infection

  MAUDE report 25319493 ↗
• InjurySep 19, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2025, THE CUSTOMER CONTACTED CLEAR CORRECT STATING THEIR PATIENT WAS SEEN AT THE EMERGENCY ROOM DUE TO SWOLLEN LIPS AFTER STARTING THEIR TREATMENT.

  Patient problems: Subclinical Infection

  MAUDE report 23097290 ↗
• InjurySep 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WITH CASE NUMBER (B)(4) HAS HAD AN ALLERGIC REACTION TO THE MATERIAL OF THE SPLINTS SUPPLIED. WE THEREFORE REQUEST A CREDIT NOTE IF POSSIBLE OR, ALTERNATIVELY, THE PROVISION OF SPLINTS MADE FROM A DIFFERENT MATERIAL. PLEASE FIND ENCLOSED THE PATIENT'S MEDICAL CERTIFICATE. THANK YOU VERY MUCH FOR YOUR ASSISTANCE. PLEASE DO NOT HESITATE TO CONTACT ME IF YOU HAVE ANY QUESTIONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22992164 ↗
• InjuryJul 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PATIENT HAS BEEN GETTING RECESSION NEAR LL3 DUE TO THE ALIGNER DIGGING INTO HER GINGIVAE THE PATIENT IS CURRENTLY ON STEP 6. I HAVE HAD TO ADJUST THE PATIENT'S ALIGNERS HERE ON A FEW OCCASIONS. COULD YOU PLEASE RE SEND OUT THE REMAINING ALIGNERS (STEP 7 TO 12) WITH A SHORTER FLANGE ON LL3 SO IT TERMINATES ABOVE GINGIVAL MARGIN? AS YOU CAN SEE FROM THE IN-SITU PHOTO, THE LL3 GINGIVAE HAVE RECESSED ON THE BUCCAL ASPECT FROM THE EXTENSION ON THE FLANGE.

  Patient problems: Insufficient Information

  MAUDE report 22436576 ↗
• InjuryMay 21, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE INCISOR OF THE PATIENT CHANGED COLOR AND BECAME PINK.

  Patient problems: Subclinical Infection

  MAUDE report 22061470 ↗
• InjuryMay 15, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS PATIENT'S TRAYS WERE DELIVERED ON APRIL 23RD AND SHE INFORMED DR. (B)(6) SHE IS HAVING AN ALLERGIC REACTION TO THE TRAYS. SHE KNOWS IT IS THE TRAYS BECAUSE THE OUTBREAK WILL DISAPPEAR WHEN THEY ARE REMOVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22029271 ↗
• InjuryApr 17, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  "PATIENT PRESENTS AN ALLERGIC REACTION. WHAT IS THE CURRENT STEP AND ARCH BEING DISCUSSED? BOTH. · PRESENCE OF A RASH? ITCHY. · PRESENCE OF SORES? NO. · PRESENCE OF SWELLING? YES. · PRESENCE OF FEVER? NO. · DIFFICULTY BREATHING? NO. · KNOWN ALLERGY TO PLASTIC? NO. · ANY ALLERGIES TO DISINFECTANTS? NO. · WAS THE PRODUCT RINSED AT SEATING? WATER. · WHAT WAS USED TO CLEAN THE PRODUCT? WATER. · DOES THE PRODUCT APPEAR TO BE CLEAN? NO. · HAS THE PATIENT SEEN AN ALLERGIST OR THEIR PRIMARY CARE PHYSICIAN? NO. · IF THE PATIENT HAS BEEN DIAGNOSES, WHAT WERE THE RESULTS? BEES. · WHAT MEASURE WERE TAKEN TO ALLEVIATE THE REACTION? STOPPED WEARING IT, TYLENOL. · INCLUDE A PHOTO OF THE ISSUE. · IS THE PRODUCT BEING RETURNED? NO."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21855083 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER CONTACTED CLEARCORRECT ON (B)(6) 2025, STATING THE PATIENT DEVELOPED A RASH IN HER MOUTH THAT SPREAD TO HER EYE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21572553 ↗
• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  "THE COMPLAINT IS ONE OF JAW JOINT POPPING DURING THE COURSE OF ALIGNER TREATMENT. NO ADDITIONAL INFORMATION REGARDING PAIN, LIMITATION OF MOVEMENT, FREQUENCY OR RESOLUTION IS PROVIDED. JOINT NOISES ARE INCIDENTAL AND GENERALLY OF NO CONSEQUENCE. OTHER CLINICAL CRITERIA ARE UTILIZED TO BETTER DETERMINE A COURSE OF ACTION. WITHOUT FURTHER DETAILS THIS SITUATION REMAINS ISOLATED AND INCONCLUSIVE. UPDATED JANUARY 28, 2025: TEMPOROMANDIBULAR JOINT DYSFUNCTION (TMD) IS A COMPLEX MULTIFACTORIAL DISORDER. MY RECOMMENDATION IS THAT THE PATIENT BE EVALUATED BY A DENTIST WHO IS FAMILIAR WITH THE EXAMINATION, DIAGNOSIS AND MANAGEMENT OF PATIENTS WITH TMD TO BE EVALUATED COMPREHENSIVELY. FOLLOWING PATIENT EXAMINATION, THE NEED FOR RADIOGRAPHIC IMAGING AND OTHER DIAGNOSTIC TESTS CAN BE DETERMINED. THE ADDITIONAL REPORT OF INTERMITTENT PAIN DOES NOT CONTRIBUTE MUCH TO UNDERSTANDING THE PATIENT'S SITUATION."

  Patient problems: Difficulty Chewing

  MAUDE report 21323007 ↗
• InjuryNov 15, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON OCTOBER 23, 2024 THE CUSTOMER CONTACTED CLEARCORRECT AND SUBMITTED A COMPLAINT DUE TO A POTENTIAL ALLERGIC REACTION WHICH RESULTED IN LIP SWELLING AND SWELLING IN THE MOUTH.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20700829 ↗
• InjuryJun 25, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  (B)(6) FROM THE PROVIDER'S OFFICE CONTACTED CUSTOMER CARE AND REPORTED THE PATIENT EXPERIENCED A POTENTIAL ALLERGIC REACTION. PATIENT REPORTED THEY HAD HIGH BLOOD PRESSURE, TINGLING IN THE HANDS AND FEET, SORES ON THEIR TONGUE AND SWELLING ON THE LIPS AND FACE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19605651 ↗
• InjuryApr 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER CONTACTED CLEARCORRECT CUSTOMER CARE AND STATED THAT THE PATIENT EXPERIENCED A POSSIBLE ALLERGIC REACTION. THE CUSTOMER STATED THE REACTION STARTED IMMEDIATELY AFTER STARTING TREATMENT. THE CLINICIAN ADVISED THE PATIENT TO CEASE TREATMENT. THE PATIENT WAS PRESCRIBED STEROID THERAPY TO TREAT THE SYMPTOMS; SYMPTOMS HAVE COMPLETELY DISSIPATED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19182209 ↗
• InjuryOct 25, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2023 THE CLINICIAN CONTACTED CLEARCORRECT SUPPORT AND STATED: THE PATIENT BEGAN TREATMENT IN THE BEGINNING OF (B)(6) 2023, AND REPORTED TO THE PRACTICE THAT SHE WOKE UP DUE TO PAIN IN HER UPPER CANINES AT 3AM; THE PAIN SEVERITY WAS 5/10, ULCERS ON HER CHEEKS AND SIDE OF TONGUE, SORENESS ON THE ROOF OF HER MOUTH AND BEHIND HER ANTERIOR TEETH, INABILITY TO SPEAK NORMALLY AT WORK, AND GENERAL DISCOMFORT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18006737 ↗
• InjuryOct 9, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2023 THE SALES REP CONTACTED SUPPORT AND STATED: PLEASE NOTE WE HAVE BEEN ADVISED BY THE CLINICIAN THAT THE PATIENT MAY BE SUFFERING ADVERSE REACTIONS TO THE ALIGNERS. (B)(6) 2023 - DR GHEORGHE EMAILED THE FOLLOWING ADVISORY: AS PER OUR PHONE CONVERSATION REGARDING MY CLEAR CORRECT PATIENT, I SAW HIM DURING A REVIEW AND INDEED HE DEVELOPED AN ALLERGY TO CC ALIGNERS. VERY UNUSUAL FOR MYSELF AS WELL AS WE DISCUSSED. HE HAD THE ALIGNERS WITH HIM AND ASKED HIM TO WEAR THEM AND MINUTES LATER THE GUM AND LIPS STARTED TO CHANGE COLOUR, DEVELOPING SMALL KIND OF BLISTERS ON GINGIVA.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17901639 ↗