ClearCorrect System Aligner (Multi-layer) (REF REF-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D865REF00031), received between Feb 4, 2021 and Nov 17, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Biocompatibility” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLEARCORRECT TERRITORY MANAGER CONTACTED CLEARCORRECT SUPPORT TO REPORT A POSSIBLE ALLERGIC REACTION. NO ADDITIONAL DETAILS WERE PROVIDED AND NO RESPONSES RECEIVED TO THREE FOLLOW UP REQUESTS. PATIENT FOLLOWED UP ON (B)(6) 2023 WITH THE FOLLOWING INFORMATION: ALIGNERS AND LIP JOURNAL DAY 1: FRIDAY (B)(6) 2023 SORES BEGIN DEVELOPING MORE AND SORENESS WORSENS. AS ONE CAN SEE, THE SORES LINE UP WITH THE BRACKETS DECIDED TO REMOVE ALIGNERS IN HOPES THE SORES WILL BEGIN HEALING DAY 3: SUNDAY SEPTEMBER 3, 2023 STARTING TO FEEL BETTER. NO ALIGNERS DAY 4: MONDAY (B)(6) 2023 LOOKING AND FEELING BETTER. NO ALIGNERS DAY 5: (B)(6) 2023 WENT TO SEE (B)(6) ABOUT THE SORES. LET HIM KNOW I REMOVED THE LINER 4 DAYS AGO BECAUSE OF SEVERE SORENESS, SWELLING AND PAIN DAY 8: FRIDAY (B)(6) 2023 1 WEEK LATER, TRYING LINER AGAIN DAY 9: SATURDAY (B)(6) 2023 SORES RETURN IMMEDIATELY AFTER PUTTING THE LINER BACK IN DAY 10: SUNDAY (B)(6) 2023 OUCH! DAY 12: TUESDAY (B)(6) 2023 GO SEE(B)(6). REMOVED BRACKETS IN HOPES THE HEALING WOULD BEGIN DAY 14: THURSDAY (B)(6) 2023 ANOTHER WEEK WITH LINER AND SORES EXTREMELY SORE. NO BRACKETS DAY 24: SUNDAY (B)(6) 2023 HELING BEGINS AGAIN. NO ALIGNERS. NO BRACKETS DAY 25: M

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18165414 ↗
• InjuryNov 15, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS PATIENT HAS BEEN HAVING ISSUES WITH HER ALIGNERS. SHE THOUGHT AT FIRST THEY NEEDED TRIMMED, AND COMPLAINED OF HER GUMS HURTING. BUT CAME TO THE CONCLUSION THAT SHE IS ALLERGIC TO A MATERIAL THAT THE ALIGNERS ARE MADE OUT OF. HER GUMS SWELLED AND BURNED EVERY TIME SHE TRIED TO WEAR THEM. SHE WENT TO THE EMERGENCY ROOM AND THEY ADVISED HER TO NOT WEAR HER ALIGNERS AND TO CONTACT OUR OFFICE FOR FURTHER ACTION ON WHAT TO DO.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18144726 ↗
• InjuryNov 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  FOLLOW UP TO A PREVIOUS COMPLAINT: ACCORDING TO THE DENTIST, THE ALIGNER HAS PUT TOO MUCH PRESSURE ON TOOTH 22. ON THE PHONE, THE DENTIST MENTIONED THAT THE TOOTH HAD EXISTING PERIODONTAL ISSUES, AND SHOULD THEREFORE, UNDER NO CIRCUMSTANCES BE INTRUDED OR EXTRUDED. HOWEVER, STEP 10 STARTED TO INTRUDE THE TOOTH AND PUT FAR TOO MUCH PRESSURE ON IT. THE TOOTH IS NOW ABSCESSED AND IS ´LEAKING´ PUSS.

  Patient problems: Subclinical Infection

  MAUDE report 18080482 ↗
• InjuryAug 1, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  CLINICIAN CALLED CONTACTED PROVIDER SERVICES AND STATED THE PATIENT'S TOOTH WAS FRACTURED AFTER WEARING THE DEVICES FOR ONE WEEK (FROM (B)(6) 2023). PATIENT STATED THEY FELT PRESSURE ON TOOTH 26 (FDI) SINCE THE FIRST DAY OF TREATMENT.

  Patient problems: Tooth Fracture

  MAUDE report 17436813 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  CUSTOMER STATED: THE PATIENT STARTED HER TRAYS ABOUT TWO WEEKS AGO AND SHE HAS BEEN HAVING SEVERE REACTIONS TO IT. THE CUSTOMER TOLD THE PATIENT TO STOP TREATMENT, AND THE PATIENT IS FEELING BETTER. PATIENT WOULD LIKE TO CANCEL THE TREATMENT BECAUSE IT'S AFFECTING HER WORK AND SLEEP. PATIENT WAS ON STEP 1 OF TREATMENT WHEN THE ISSUE WAS DETECTED. PATIENT STATED THEY HAD DIFFICULTY BREATHING, NAUSEA, HEADACHES, AND AN UPSET STOMACH. PATIENT HAS NO PRESENCE OF RASH, SORES, SWELLING, OR FEVER. PATIENT DOES NOT HAVE ANY KNOWN ALLERGIES TO PLASTIC OR DISINFECTANTS. PATIENT HAS NOT SEEN AN ALLERGIST OR PRIMARY CARE PHYSICIAN AT THIS TIME, SO NO DIAGNOSIS HAS BEEN MADE. THE PRODUCT WAS RINSED WITH WATER BEFORE SEATING AND APPEARED TO BE CLEAN BEFORE USE. CUSTOMER ATTEMPTED TO TRIM THE POSTERIOR OF THE DEVICES TO ALLEVIATE REACTION BUT IT DID NOT RESOLVE THE ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17297846 ↗
• InjuryMar 31, 2023Biocompatibility; Biocompatibility

  PATIENT HAS BEEN EXPERIENCING VERY SORE AND SWOLLEN TONGUE. TONGUE IS SENSITIVE TO SALT AND HEAT, AND HE IS EXPERIENCING LOSS OF TASTE. PATIENT SAYS THE WHOLE MOUTH FEELS SLIGHTLY NUMB AND IS EXPERIENCING A TINGLING SENSATION. SAYS THAT AFTER A WEEK OF NOT WEARING ALIGNERS THE SYMPTOMS SEEMED TO DISAPPEAR, HOWEVER, THAT AFTER WEARING THEM AGAIN THEY RETURNED. IT WAS RECOMMENDED TO THE PROVIDER TO STOP TREATMENT AND HAVE THE PATIENT DO AN ALLERGY TEST AND FOR A QUICK TEST TO DO A SKIN TEST TO SEE IF THIS WOULD RESULT IN A RASH OR OTHER REACTION. PATIENT RESPONSES: WHAT IS THE CURRENT STEP AND ARCH BEING DISCUSSED? STEP 9 THE DENTIST ADVISED ME TO STOP WEARING THE CLEARCORRECT AND ALSO TO TEST WITH A PIECE OF THE PLASTIC CUT OFF THE OLDER BRACES AND TAPE IT ON MY SKIN. TO SEE IF ANY RASH APPEARS. PRESENCE OF A RASH? THE INSIDE OF MY MOUTH WAS VERY RED AND SENSITIVE TO HEAT AND SALT. PRESENCE OF SORES? YES, THERE WERE SOME SORES ON MY TONGUE. PRESENCE OF SWELLING? YES, MY TONGUE WAS SWOLLEN: PRESENCE OF FEVER? NO. DIFFICULTY BREATHING? NO. KNOWN ALLERGY TO PLASTIC? NO. ANY ALLERGIES TO DISINFECTANTS? NO. WAS THE PRODUCT RINSED AT SEATING? YES. WHAT WAS USED TO CLEAN THE PRODUCT? WATER

  Patient problems: Local Reaction

  MAUDE report 16656579 ↗
• InjuryOct 20, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER THE CANDID CO, THE PATIENT REPORTS TMJ ISSUES, AND THAT THEY'VE SEEN A SPECIALIST THAT PRESCRIBED A JAW SPLINT. THE PATIENT FIRST REPORTED THEIR BITE BEING OFF IN (B)(6) 2021, DURING TREATMENT. HOWEVER, BITE ISSUES ARE A KNOWN AND DISCLOSED SIDE EFFECT OF ALL ORTHODONTIC TREATMENT. ON (B)(6) 2021, THE PATIENT REPORTED THAT THEY'D SEEN THE JAW SPECIALIST AND REQUIRED A JAW SPLINT. A PRODUCT RETURN IS NOT POSSIBLE, BECAUSE THE PATIENT ALLEGES THAT TREATMENT, OVERALL, HAS CAUSED THIS ISSUE, AND NOT A SPECIFIC STEP, ARCH, OR DEVICE. THERE ARE NO REPORTS OF THE DEVICE BEING ALTERED AND NO PHOTOS OF THE DEVICES.

  Patient problems: Difficulty Chewing

  MAUDE report 15638794 ↗
• InjuryOct 19, 2022Biocompatibility; Biocompatibility

  THE CUSTOMER REPORTS THE PATIENT STARTED EXPERIENCING AN ITCHY AND PAINFUL THROAT AFTER THE FIRST NIGHT OF WEARING THE ALIGNERS. THE FOLLOWING MORNING A RASH WAS PRESENT ON THE LEFT SIDE OF THE PATIENT'S FACE AND SOME SLIGHT SWELLING OF THE GUMS. THERE WAS NO FEVER, SORES, OR DIFFICULTY BREATHING. PATIENT HAS NO KNOWN ALLERGIES TO PLASTIC OR DISINFECTANTS. THE PRODUCT WAS WASHED WITH WATER PRIOR TO INSERTION. THE CUSTOMER HAD THE PATIENT IMMEDIATELY STOP WEARING THE ALIGNERS AND THE GUMS ARE NOW BETTER. NO MENTION OF THE THROAT PAIN OR RASH ALLEVIATION.

  Patient problems: Local Reaction

  MAUDE report 15635762 ↗
• InjuryOct 19, 2022Biocompatibility; Biocompatibility

  DR. (B)(6) REPORTED THAT HER PATIENT AFTER WEARING THE 2ND TRAY BEGIN TO HAVE DIFFICULTY BREATHING. THE PATIENT PREVIOUSLY SUFFERED FROM ASTHMA PER DR. (B)(6). SHE INDICATED THAT HE STARTED USING AN INHALER BUT ALSO INDICATED THAT HE HAD NOT HAD ASTHMA IN OVER 5 YEARS UNTIL WARING THE ALIGNERS. SHE HAD THE PATIENT STOP WEARING THE ALIGNERS AND CALLED TO ASK ABOUT STOPPING THE CASE AND ASKED ABOUT THE MATERIAL. THERE IS NO PRESENCE OF A RASH, SORES, SWELLING, OR FEVER. THE PATIENT HAS NOT GONE TO SEE THEIR PRIMARY CARE PHYSICIAN AND NO INDICATION OF WHETHER OR NOT HE WILL.

  Patient problems: Anaphylactic Shock

  MAUDE report 15633197 ↗
• InjuryOct 19, 2022Biocompatibility; Biocompatibility

  PROVIDER'S OFFICE CALLED IN TO SAY THE PATIENT WAS HAVING AN ALLERGIC REACTION TO THE ALIGNERS. SHE SAID THE PATIENT WAS HAVING A HARD TIME BREATHING AND SWELLING IN THE MOUTH. THE PATIENT IS NOT CURRENTLY WEARING THE ALIGNERS AND SHOULD BE SENDING BACK THE ALIGNERS WITH THE SHIPPING LABEL PROVIDED. PROVIDER STATES THE PATIENT HAS NO PRESENCE OF A RASH OR FEVER, HOWEVER, THERE ARE SORES PRESENT ALONG WITH A RED THROAT, AND ANAPHYLAXIS. PRIOR TO TREATMENT THERE WAS NO KNOWN ALLERGY TO PLASTIC OR ANY OTHER ALLERGIES. AFTER THE ISSUE WAS REPORTED THE PATIENT THEN STATED SHE IS ALLERGIC TO A LOT OF THINGS (THIS WAS NOT EXPANDED ON). THE ALIGNER WAS NOT RINSED OR CLEANED WITH ANYTHING, IT WAS STATED "THE ALIGNER WAS PULLED STRAIGHT FROM THE PACKAGE". THE PATIENT IS NO LONGER WEARING THE ALIGNERS AND PLANS TO SEE HER PRIMARY CARE PHYSICIAN AFTER SHE GETS BACK INTO FROM VACATION. PATIENT HAS NOT REPORTED BACK TO THE PROVIDER.

  Patient problems: Local Reaction

  MAUDE report 15632203 ↗
• InjuryAug 25, 2022Biocompatibility; Biocompatibility

  CLEARCORRECT'S CUSTOMER (B)(6) RECEIVED AN EMAIL FROM THEIR SUPPORT TEAM MEMBER STATING: "WE ARE REACHING OUT TO YOU IN REGARDS TO ONE OF OUR PATIENTS , ALSO A INFLUENCER WE ARE CURRENTLY TREATING. HE WAS WEARING HIS ALIGNERS FOR 2 DAYS WITH NO SYMPTOMS OR REACTIONS BUT ON DAY 3 AFTER HE REMOVED THE ALIGNER TO EAT, HE THEN ADDED THE CHEWIES AND AFTERWARDS PUT BACK THE ALIGNER AGAIN. WITHIN A SHORT PERIOD OF TIME AFTER PUTTING THE ALIGNERS IN AGAIN HIS GUM STARTED SWELLING, HE EXPRESSES IT AS IF THE ALIGNER CUT INTO HIS GUM AND THAT THE PAIN WAS SEVERE. HE ALSO STARTED TO FEEL TINGLING IN THE THROAT AND THE TONGUE. SHORT AFTER HE PASSED OUT AND THE AMBULANCE HAD TO COME. IN THE HOSPITAL, THE DOCTORS TOLD HIM HE HAD A ALLERGIC REACTION BUT TO WHAT THEY DID NOT KNOW. WE TOLD (B)(6) TO STOP WEARING THE ALIGNERS AND CHEWIES AND WAIT FOR FURTHER INSTRUCTIONS. (B)(6) FROM (B)(6) REACH OUT TO CLEARCORRECT AND A MEETING WAS CONDUCTED ON (B)(6) 2022. THE FOLLOWING ADDITIONAL INFORMATION WAS COLLECTED: (B)(6) PATIENT IS LOCATED IN (B)(6). THE PATIENT WORE STEP 1 UPPER AND LOWER ALIGNER FOR 5 DAYS PRIOR TO THE EVENT WITH NO ISSUES. ON THE DAY OF THE EVENT, THE PATIENT HAD EATEN PASTA AND THEN

  Patient problems: Local Reaction

  MAUDE report 15294015 ↗
• InjuryAug 25, 2022Biocompatibility; Biocompatibility

  THE PROVIDER LET US KNOW THAT THE PATIENT HAD A BAD ALLERGIC REACTION TO THE ALIGNERS. THE PATIENT'S GINGIVA BECAME VERY INFLAMED WITHIN A DAY AND HER ENTIRE LIP SWELLED. SHE TRIED WEARING THE ALIGNERS FOR A WEEK AND THE GUMS KEPT GETTING BIGGER AND DID NOT GO AWAY. THE PATIENT DID NOT SEE A MD. SHE STOPPED WEARING THE TRAYS AND THE SWELLING AND INFLAMMATION WENT AWAY. THERE WAS NO PRESENCE OF A RASH, HOWEVER, THE PATIENT DID HAVE SORES ORALLY ALONG WITH SWELLING. NO KNOWN FEVER, ALLERGIES TO PLASTIC OR DISINFECTANTS AND NO DIFFICULTY BREATHING. WATER WAS USED TO RINSE THE ALIGNERS PRIOR TO SEATING AND ONLY WATER AND A TOOTHBRUSH WERE USED TO CLEAN THE ALIGNERS. PRODUCT APPEARS TO BE CLEAN PATIENT DID NOT SEE AN ALLERGIST OR PRIMARY CARE PHYSICIAN. PATIENT WAS INSTRUCTED TO STOP WEARING THE ALIGNERS AND IT ALLEVIATED THE ISSUES SHE WAS HAVING.

  Patient problems: Local Reaction

  MAUDE report 15293927 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER FOR CASE (B)(4) STATES THE PATIENT WAS DIAGNOSED WITH PANCREATITIS DUE TO ALIGNER WEAR. THE PATIENT IS SEEING THEIR PRIMARY CARE PHYSICIAN ON (B)(6) 2022, TO OBTAIN THE MEDICAL RECORDS THAT SHOW THE DIAGNOSIS.

  Patient problems: Pancreatitis

  MAUDE report 15293917 ↗
• InjuryApr 25, 2022Biocompatibility; Biocompatibility

  ON (B)(6) 2022, THE CUSTOMER FOR CASE (B)(4) CALLED IN AND STATED THE PATIENT WAS HAVING AN ALLERGIC REACTION FROM WEARING THE STEP 1 ALIGNERS AFTER A FULL WEEK OF WEAR. THE PATIENT PRESENTED WITH A RASH, SORES IN THE MOUTH, AND SWELLING. THERE WAS NO FEVER OR DIFFICULTY BREATHING. THE PATIENT, AT THE TIME, DID NOT KNOW OF AN ALLERGY TO PLASTIC BUT HAS SINCE SEEN A DERMATOLOGIST AND WAS DIAGNOSED WITH A PLASTIC ALLERGY. THE ALIGNER WAS CLEANED WITH WATER ONLY PRIOR TO WEAR.

  Patient problems: Local Reaction

  MAUDE report 14193017 ↗
• InjuryDec 16, 2021Biocompatibility; Biocompatibility

  ON (B)(6) 2021 (B)(6) WITH THE PROVIDER'S OFFICE CALLED ABOUT CASE (B)(4) AND SAYS THAT THE PATIENT WAS HAVING AN ALLERGIC REACTION TO THE ALIGNERS. THE PATIENT DID NOT PROGRESS PAST STEP 1 ALIGNER WHEN THE REACTION WAS NOTICED. THE PROVIDER SERVICES SPECIALIST WAS INFORMED THAT THE ALIGNERS MADE THE PATIENT'S HANDS RED, HER THROAT BECAME ITCHY AND IRRITABLE, AND HER LIPS STARTED SWELLING. THE PROVIDER SERVICES SPECIALIST WAS INFORMED THAT THE ALIGNER CAUSED THE PATIENT TO HAVE AN ASTHMA ATTACK. (B)(6) WITH THE PROVIDER'S OFFICE STATED THE PATIENT HAD TO GO TO THE PULMONARY DOCTOR REGARDING THE EVENT. THE PROVIDER SERVICES SPECIALIST WAS INFORMED THAT THE PATIENT HAS MANY ALLERGIES, BUT (B)(6) WITH THE PROVIDER'S OFFICE WAS NOT SURE IF PLASTIC WAS ONE OF THEM. PER (B)(6), THE PROVIDER AND THE CUSTOMER ONLY RINSE THE ALIGNERS WITH WATER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13019112 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SITUATION REPORTED TO CLEARCORRECT: THE CUSTOMER STATES STEP 1 LOWER ALIGNER WAS CAUSING BRUISING AND GUM RECESSION ON THE LOWER ANTERIOR. THE CUSTOMER ALSO REPORTED THAT THE GUMS LOOK BRUISED, EXTREMELY PAINFUL, AT FIRST THERE WERE BLEEDING SPOTS, THEN THE GUMS SLOUGHED AND WAS RAW. THE CUSTOMER HAD THE PATIENT APPLY HEALING OINTMENT TO ALLEVIATE THE SITUATION. THE PATIENT DOES NOT HAVE ANY PREDISPOSING GUM PROBLEMS, OR VIRAL OR TRAUMATIC ULCERS. CUSTOMER FEELS THAT THE TRIMLINE DESIGN NOT CUTTING OFF AT THE GINGIVAL MARGIN CREATES A NEGATIVE FLUID PRESSURE OF AIR AND SALIVA WHICH MAY ADHERE TO THE ALIGNER SURFACE CREATING A PARTIAL VACUUM, WHEREIN WHEN THE ALIGNERS ARE REMOVED, THEY MAY INADVERTENTLY STRIP THE GUMS.

  Patient problems: Bruise/Contusion

  MAUDE report 11554536 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 23, 2020 THE PATIENT CALLED IN STATING THAT SHE SOUGHT CONSULTATION FROM OTHER DENTISTS FOR CASE #(B)(4). THE PATIENT STATED THAT HER CURRENT TREATMENT HAS CAUSED DAMAGE THAT CLEAR ALIGNERS CANNOT FIX. THE PATIENT SAID SHE IS IN PAIN AND CANNOT MOVE PART OF HER JAW. SHE STATED THAT SHE HAS AN OVERJET OVER 40% ON ONE SIDE. THE DOCTOR OF THE PATIENT SAID, "NO PAIN HAS BEEN REPORTED DURING HER TREATMENT. SHE HAS HAD SEVERAL REFINEMENTS AND REQUESTS FOR MINOR ROTATIONS OR MOVEMENTS TO PERFECT THINGS. SOME ARE REASONABLE AND POSSIBLE, AND SOME ARE NOT, GIVEN HER OCCLUSION AND PRESENTING JAW STRUCTURE. THIS WAS EXPLAINED TO HER MANY TIMES. EVERY ATTEMPT HAS BEEN AND IS STILL BEING MADE TO SATISFY HER REQUESTS."

  Patient problems: Pain

  MAUDE report 11280541 ↗