Invisalign System - Moderate 9001Recalls & reported problems
Align Technology, Inc. · Sequential Aligners · Class 2
Quick summary
This is the Invisalign clear aligner system, a set of sequential plastic trays that gradually straighten teeth. The 27 reports mostly describe teeth that later cracked at the gum line or were lost and had to be extracted, along with pain, jaw locking, and discoloration of a front tooth. No deaths were reported, and all 27 reports were injuries. There are no recalls naming this device. Reports rose sharply in the past 12 months, from 3 to 13.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00816063020196), received between Oct 25, 2022 and Jul 27, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
- Appropriate Device Problem Term/Code Not Available8
- Insufficient Device Problem Information2
- Sharp Edges1
Patient problems
- Tooth Loss24
- Tooth Fracture8
- Pain4
- Unspecified Infection2
- Abscess1
- Discomfort1
- Fistula1
- Inflammation1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
The treating doctor reported that the patient had symptoms of severe pain in tooth 2.4 that after evaluation, ended in an extraction.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 50008577 ↗InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAS BEEN DIAGNOSED WITH LEFT TEMPOROMANDIBULAR JOINT (TMJ) ANTERIOR DISC DISPLACEMENT WITHOUT REDUCTION, HAD SYMPTOMS OF JAW LOCKING ON THE LEFT SIDE, INABILITY TO OPEN THE MOUTH PROPERLY, AND PAIN UPON ATTEMPTING TO OPEN THE MOUTH, AS WELL AS SENSITIVITY WHILE EATING AND SPEAKING. THE PATIENT REPORTED VISITING A SPECIALIST AND REQUIRED MEDICAL INTERVENTION CONSISTING OF ARTHROCENTESIS, WITH REGENERATIVE MEDICINE PLANNED. THE PATIENT INDICATED TAKING A MUSCLE RELAXANT TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON 12/9/2025 AND THE PATIENT IS CURRENTLY EXPERIENCING MILD PERSISTENT SYMPTOMS, INCLUDING SENSITIVITY WHILE EATING AND SPEAKING
Patient problems: Joint locking; Loss of Range of Motion; Pain; Sensitivity of Teeth
MAUDE report 25795834 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD THE SYMPTOM OF TOOTH EXTRACTION OF UL4 DUE TO DEVITALIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.
Patient problems: Tooth Loss
MAUDE report 25692762 ↗InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH FRACTURE AND TOOTH LOSS INVOLVING UL5 AND UL6, WHICH SPLIT AND BROKE AT THE GUM LEVEL DURING TREATMENT AND WERE SUBSEQUENTLY EXTRACTED. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION AS A RESULT OF THE EVENT. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON AN UNKNOWN DATE AND THE PATIENT IS CURRENTLY ASYMPTOMATIC.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 25621258 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF PAIN, DISCOMFORT, THE APPEARANCE OF A SMALL LUMP (FISTULA), AND GRADE III MOBILITY AFFECTING TOOTH 3.3 REQUIRING AT THE END TOOTH EXTRACTION. THE PATIENT REPORTED VISITING A PERIODONTIST THAT DETERMINED THE BAD CONDITION OF THE TOOTH AND DECIDED HE EXTRACTION. THE PATIENT INDICATED BEING PRESCRIBED ANTIBIOTICS TO MANAGE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING TREATMENT WITH THE INVISALIGN SYSTEM AND IS CURRENTLY REPORTED TO HAVE NO PAIN, DISCOMFORT, OR INFECTION FOLLOWING THE EXTRACTION OF TOOTH 3.3.
Patient problems: Discomfort; Fistula; Pain; Tooth Loss
MAUDE report 24895937 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF EXTRACTION OF TOOTH #18. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.
Patient problems: Tooth Loss
MAUDE report 24859407 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF LOSS OF TOOTH 1.5 DUE TO FRACTURE AND SENSITIVITY OF TOOTH 1.4. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 24414852 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT STARTED DEVELOPING SYMPTOMS OF DISCOLORATION OF THE UPPER LEFT CENTRAL INCISOR ON (B)(6) 2025. ON (B)(6) 2025, ELECTIVE ENDODONTIC TREATMENT WAS PERFORMED ON TOOTH 2.1. ON (B)(6) 2026, AGAIN PRESENTED SENSITIVITY TO HOT AND COLD ON TOOTH 1.1. AN IOPA WAS PERFORMED TO EVALUATE, NO SIGNIFICANT FINDINGS, HOWEVER; WHEN A CBCT WAS PERFORMED, REVEALED A FRACTURE OF THE ANTERIOR MAXILLA. THE PATIENT DID NOT REPORT HAVING ANY PRE-EXISTING MEDICAL CONDITIONS AND DID NOT TAKE ANY MEDICATIONS REGULARLY. THE PATIENT INDICATED BEING PRESCRIBED STEROIDS DEXAMETHASONE 4 MG TWICE DAILY FOR THREE DAYS AND PARACETAMOL (PCM) 1 G THREE TIMES DAILY FOR THREE DAYS TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2026 AND THE PATIENT IS CURRENTLY AWAITING FURTHER GUIDANCE WHILE PLACED ON RETAINERS.
Patient problems: Necrosis; Skull Fracture
MAUDE report 24369065 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED SYMPTOMS OF LOSS OF TEETH 2.4 AND 2.5. THE PATIENT DID NOT REPORT REQUIRING ANY ADDITIONAL MEDICAL INTERVENTION OTHER THAN THE TOOTH EXTRACTIONS THEMSELVES. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING SPECIFIC MEDICAL INTERVENTIONS BEYOND THE EXTRACTIONS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS.
Patient problems: Tooth Loss
MAUDE report 24250521 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT EXPERIENCED THE SYMPTOM OF LOSS OF TOOTH UR1. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AND WAS NOT PRESCRIBED ANY MEDICATIONS TO ADDRESS THE REPORTED EVENT. THE PATIENT CONTINUED WEARING THE ALIGNERS, AND THE TREATING DOCTOR CONFIRMED THE PATIENT IS CURRENTLY DOING WELL.
Patient problems: Tooth Loss
MAUDE report 24240246 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR SHARED THAT THE PATIENTS TOOTH ROOT WAS FRACTURED AND AN AVULSION WAS PERFORMED (TOOTH 2.1) AND WILL REQUIRE AN IMPLANT. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTION OR MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED. NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 23989238 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THE PATIENT LOST TOOTH 1.7. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Tooth Loss
MAUDE report 23742723 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT'S TOOTH #4 FRACTURED DURING USE OF THE LAST ALIGNER AND WAS SUBSEQUENTLY EXTRACTED. NO FURTHER MEDICAL INTERVENTION NECESSARY AND NO MEDICATIONS WERE REQUIRED.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 23617139 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED EXTRACTION OF TOOTH (3.6). IT IS UNKNOWN IF THE PATIENT REQUIRED MEDICAL INTERVENTION OR IF MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Tooth Loss
MAUDE report 23017582 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTS THAT THE PATIENT HAD PAIN FOR A COUPLE OF WEEKS, REQUIRED TO HAVE EMERGENCY DENTAL TREATMENT AND REQUIRED TOOTH UL7 TO BE EXTRACTED. THE REPORTED SYMPTOMS DO NOT APPEAR TO BE LIFE THREATENING TO THE PATIENT, EITHER INDIVIDUALLY OR IN COMBINATION OF SYMPTOMS. IT IS UNKNOWN IF MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE REPORTED SYMPTOMS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tooth Loss
MAUDE report 22554957 ↗InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT LOST TOOTH #8. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, AND NO MEDICATIONS WERE PRESCRIBED. THE PATIENT DISCONTINUED THE USE OF THE UPPER ALIGNER TREATMENT IN (B)(6) 2024.
Patient problems: Tooth Loss
MAUDE report 21681405 ↗InjuryAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF SEVERE ABSCESS ON UR1 AND TOOTH EXTRACTION (UR1). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Abscess; Tooth Loss
MAUDE report 20081234 ↗InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOM OF FRACTURE AND LOSS OF TOOTH 1.3. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 19671220 ↗InjuryApr 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH #30 SPLIT IN HALF, INFECTION AND TOOTH EXTRACTION (TOOTH #30). THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION, DENTIST, TO ALLEVIATE THE REPORTED SYMPTOMS OF FRACTURE, INFECTION, AND THE EXTRACTION OF TOOTH #30. THE TREATING DOCTOR REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATING DOCTOR REPORTED THAT THE PATIENT IS CONTINUING TO USE THE ALIGNERS (REQUESTED MORE ALIGNERS THROUGH WARRANTY REQUEST) AND IS CURRENTLY ASYMPTOMATIC.
Patient problems: Tooth Fracture; Tooth Loss; Unspecified Infection
MAUDE report 19043085 ↗InjuryApr 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOM OF AVULSION OF WHOLE TOOTH 4.3, WHEN REMOVING THE PATIENT'S FIRST ALIGNER POST EXTRACTION. THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED THE FOLLOWING MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM OF TOOTH AVULSION OF 4.3: PATIENT REQUIRED A SPLINT FOR 3 WEEKS. IT IS UNKNOWN IF MEDICATIONS WERE PRESCRIBED OR USED TO ALLEVIATE THE PATIENT'S REPORTED SYMPTOM. THE TREATING DOCTOR REPORTED THAT THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS AND IS CURRENTLY GETTING BETTER.
Patient problems: Tooth Loss
MAUDE report 19028914 ↗InjuryNov 14, 2023Sharp Edges; Sharp Edges
THE TREATING DOCTOR REPORTED THAT THE PATIENT REPORTED THE SYMPTOMS OF SWOLLEN TONGUE, CUT ON THE TONGUE, INFECTION, AND PAIN. IT IS NOTED, THAT FROM THE HOSPITAL CERTIFICATE, THE PATIENT ALSO PRESENTED SYMPTOMS OF WHITE LESIONS ON THE TONGUE, CHEEKS, AND PALATE. THE PATIENT REPORTED REQUIRING A VISIT TO THE DENTAL OFFICE, WHERE THE PATIENT WAS PRESCRIBED ANTI-INFLAMMATORY SPRAY AND BALM, TO ALLEVIATE THE REPORTED SYMPTOMS. IT WAS REPORTED THAT THE TREATING DOCTOR POLISHED THE ALIGNERS TO REMOVE ANY SHARP EDGES. THE PATIENT REPORTED GOING BACK TO THE DENTAL OFFICE AND THE TREATING DOCTOR RECOMMENDED THAT THE PATIENT SHOULD GO TO THE HOSPITAL. THE PATIENT REPORTED HOSPITALIZATION (PATIENT REPORTED 1 WEEK HOSPITALIZATION, WHILE HOSPITAL CERTIFICATE REFLECTS 1 DAY HOSPITALIZATION ON 05/15/23 TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING DIAGNOSED AT HOSPITAL WITH GLOSSITIS. WHILE IN THE HOSPITAL, THE PATIENT REPORTED BEING PRESCRIBED ANTI-INFLAMMATORY, ANALGESICS, AND INTRAVENOUS ANTIBIOTICS TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATING DOCTOR REPORTED THAT THE PATIENT DISCONTINUED THE USE OF THE ALIGNERS AROUND (B)(6) 2023. HOSPITALIZATION WAS REPORTED TO HAVE OCC
Patient problems: Pain; Swelling/ Edema; Ulcer; Unspecified Infection
MAUDE report 18131937 ↗InjurySep 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED SYMPTOMS OF BONE RESORPTION AND TOOTH LOSS (UNSPECIFIED TOOTH #). IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Loss
MAUDE report 17685660 ↗InjuryJul 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED SYMPTOMS OF TOOTH INFECTION AND EXTRACTION ON LR5. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Loss
MAUDE report 17346949 ↗InjuryApr 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED SYMPTOMS OF ABSCESS ON TOOTH UL7 AND EXTRACTION OF UL7. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Loss
MAUDE report 16668395 ↗InjuryApr 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT REPORTED THE EXTRACTION OF TOOTH UL7 DUE TO FRACTURE. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 16667632 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.