Invisalign Full 8500Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00816063020004), received between Feb 8, 2017 and Dec 2, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATED PATIENT REPORTED HAVING A TOOTH EXTRACTED FROM THE LOWER ARCH (UNKNOWN TOOTH), ALONG WITH EXPERIENCING DISCOMFORT AND CUTS. WHEN THE CLINIC WAS CONTACTED, THE STAFF EXPLAINED THAT THIS IS AN OLD CASE AND THAT THEY TYPICALLY DO NOT RECOMMEND EXTRACTIONS. THE EXTRACTIONS WERE PERFORMED BY THE PATIENT'S GENERAL DENTIST, AND THE CLINIC IS UNAWARE OF THE REASON FOR THESE PROCEDURES. THE CLINIC STAFF CLARIFIED THAT THERE WERE NO NOTES INDICATING THAT THE ALIGNERS CAUSED HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort; Laceration(s); Tooth Loss

  MAUDE report 23696086 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT IN (B)(6) 2023, THE PATIENT NOTICED THAT HER FRONT TEETH APPEARED AS IF THEY WERE GOING TO FALL OUT. THE PATIENT CONTACTED THE DENTAL OFFICE, WHERE X-RAYS WERE TAKEN, AND SHE WAS INFORMED THAT THE AFFECTED TOOTH COULD NOT BE SAVED (ACCORDING TO RECORDS AND TREATING DOCTOR INFORMATION, NO TEETH WERE EXTRACTED AT THE END). THE PATIENT WAS SUBSEQUENTLY REFERRED TO A PERIODONTIST. THE PATIENT LATER LEARNED THAT HAD A GUM INFECTION REQUIRING SURGICAL INTERVENTION IN TWO STAGES. THE FIRST SURGERY OCCURRED ON (B)(6) 2024, AND THE SECOND SURGERY WAS PERFORMED APPROXIMATELY EIGHT MONTHS LATER. FOLLOWING COMPLETION OF THE SURGERIES, THE PATIENT WAS ADVISED THAT SHE WOULD NOT BE ABLE TO WEAR ALIGNERS FOR ONE YEAR. THE TREATING DOCTOR STATED THAT THE LAST TIME THAT SAW THE PATIENT WAS IN 2024 AND CONFIRMED THAT THE PATIENT HAD GUM ISSUES AND VISITED A PERIODONTIST. IT IS UNKNOWN IF FURTHER MEDICAL INTERVENTION OR IF THE PATIENT REQUIRED ANY MEDICATION, SINCE ACCORDING TO THE TREATING DOCTOR, THE PATIENT NEVER WENT BACK TO THE OFFICE AFTER VISITING THE PERIODONTIST.

  Patient problems: Bacterial Infection

  MAUDE report 23464879 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE ALIGNER TREATMENT MADE THE PATIENT'S MIGRAINES WORSE IN 2020 AND REPORTED BEING HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Headache

  MAUDE report 20864140 ↗
• InjuryJun 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED DIRECTLY TO ALIGN THE FOLLOWING SYMPTOMS: DISLOCATED JAW, JAW PAIN AND SWELLING, SHATTERED TMJ JOINT, WHICH REQUIRED MULTIPLE TMJ SURGERIES AND RESULTED IN A BACTERIAL INFECTION, BITE ISSUES, AND CONTINUED JAW PAIN. THE PATIENT REPORTED REQUIRING MEDICATIONS FOR THE BACTERIAL (STAPH) INFECTION, BOTOX AND PHYSICAL THERAPY FOR TMJ PAIN, IN ADDITION TO THE REPORTED TMJ SURGERIES AND VISITS TO THE ORAL SURGEON. THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS (DATE UNKNOWN).

  Patient problems: Bacterial Infection; Joint Dislocation; Pain; Swelling/ Edema

  MAUDE report 19563583 ↗
• InjuryJan 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT DIRECTLY REPORTED THE FOLLOWING: PATIENT REPORTED SYMPTOM OF VERTIGO, WHICH LED TO HOSPITALIZATION IN (B)(6) 2023. THE TREATING DOCTOR SHARED THAT THEY WERE UNAWARE OF THE PATIENT'S REPORTED SYMPTOMS.THE PATIENT REPORTED REQUIRING HOSPITALIZATION IN (B)(6) 2023 AND VISITING A CHIROPRACTOR IN (B)(6) 2023 TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT REPORTED TAKING ANTI-NAUSEA MEDICATION AT THE HOSPITAL (WHICH CAUSED THE PATIENT TO THROW UP) TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT IS STILL WEARING THE ALIGNERS.

  Patient problems: Vertigo

  MAUDE report 18567049 ↗
• InjuryJan 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT DIRECTLY REPORTED THE FOLLOWING: THE PATIENT REPORTED SYMPTOMS OF BONE LOSS, TOOTH EXTRACTION (TOOTH #25 AND #26) AND IMPLANTS REQUIRED (TOOTH #25 AND #26). IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY PRESCRIPTION MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED FINISHING THE INVISALIGN TREATMENT IN (B)(6) 2021, AND IS CURRENTLY WEARING RETAINERS (NOT AN ALIGN TECHNOLOGY INC. PRODUCT).

  Patient problems: Tooth Loss

  MAUDE report 18566669 ↗
• InjuryJun 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED PUSTULE ON THE BUCCAL OF LL2, NEAR THE APEX AREA, ROOT CANAL WAS PERFORMED, AND EXTRACTION OF TOOTH LL2. THE PATIENT REPORTED REQUIRING VISITING AN ENDODONTIST SPECIALIST TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS STILL WEARING THE ALIGNERS AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Tooth Loss

  MAUDE report 17101120 ↗
• InjuryMar 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOM OF "TOOTH FALLING" (LOSS OF TOOTH - TOOTH NUMBER UNSPECIFIED). IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.

  Patient problems: Tooth Loss

  MAUDE report 16659910 ↗
• InjuryJun 4, 2018Patient-Device Incompatibility

  I JUST RECEIVED MY INVISALIGN ALIGNERS ON THURSDAY, (B)(6) 2018 AND AFTER I PUT THEM IN WHILE AT THE ORTHODONTIST, I STARTED FEELING STRANGE SENSORY EXPERIENCE, LIKE A MIGRAINE AURA. TRYING TO IGNORE IT, I PUT THEM IN AND OUT A FEW TIMES TO LEARN THE PROCESS. I GOT OUT OF THE CHAIR AND WAS DIZZY AND HAD BLURRED VISION. I WENT TO A SINK WHERE I DID A FLUORIDE RINSE (NEVER HAD ADVERSE REACTION TO FLUORIDE BEFORE) AND SPIT IT OUT. I PUT THE ALIGNERS IN AND WENT UP TO MAKE MY NEXT APPOINTMENT. FELT STRANGE AND THEN MY MOUTH STARTED WATERING AND I WAS NAUSEOUS AND I ASKED FOR A BOTTLE OF WATER. I DRANK HALF AND HAD TO RUN TO THE BATHROOM TO VOMIT. I TOOK THE ALIGNERS OUT. I WAS STILL VERY NAUSEOUS, I ASKED THE LADY IF IT WAS A SIDE EFFECT AND SHE THOUGHT MAYBE IT WAS FROM THE FLUORIDE RINSE. I GRABBED ANOTHER BOTTLE OF WATER AND SOME NAPKINS AND WENT TO THE PARKING LOT WHERE I PROCEEDED TO HAVE NAUSEA, DROOL AND CONTINUED TO HEAVE. I HAD THE NAUSEA AND DISORIENTATION FOR ABOUT ANOTHER HOUR OR TWO. LATER THAT EVENING I THOUGHT I'D TRY THE ALIGNERS AGAIN. I FELT TIRED AND NAUSEOUS, GOT SWEATS AND GOOSE BUMPS AND HAD DIGESTIVE ISSUES. I SLEPT IN THE ALIGNERS AND IN THE MORNING STILL FELT S

  Patient problems: Blurred Vision; Burning Sensation; Diarrhea; Dizziness; Headache; Nausea; Swelling; Vomiting

  MAUDE report 7568663 ↗
• InjuryFeb 8, 2017Adverse Event Without Identified Device or Use Problem

  HAVE BEEN USING INVISALIGN FOR 2 DAYS. HAVE SEVERE SORE THROAT AND THROAT BURNING.

  Patient problems: Burning Sensation; Sore Throat

  MAUDE report 6321741 ↗