Invisalign System - Lite 9002Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00816063020202), received between Sep 22, 2022 and Feb 9, 2026 — classified as 20 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED THE EXTRACTION OF TOOTH #19. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 24293195 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR SHARED THAT THE PATIENT DEVELOPED PAIN ON TOOTH #16, THERE WAS A FRACTURE IN THIS TOOTH AND REQUIRED EXTRACTION. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTION OR MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 24095378 ↗
• 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 DEVELOPED MOBILITY ON TOOTH #4, BONE LOSS AND LASTLY REQUIRED EXTRACTION OF THIS TOOTH. THE PATIENT REQUIRED A BONE GRAFT, AND AN IMPLANT WILL BE PLACED IN THE FUTURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Erosion; Tooth Loss

  MAUDE report 23617223 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THE PATIENT REQUIRED TOOTH EXTRACTION (TOOTH #15), WHICH INITIALLY HAD NO PERIODONTAL CONDITION, NO TRAUMATIC OCCLUSION, AND A GOOD PROGNOSIS, WITH NO EXPECTATION OF EXTRACTION DURING TREATMENT. THE TREATING DOCTOR STATED THAT PRIOR TO ALIGNER USE, THE TOOTH WAS STABLE, BUT AFTER TREATMENT BEGAN, THE PATIENT EXPERIENCED SIGNIFICANT BONE LOSS AND CLASS III MOBILITY, LEADING TO EXTRACTION. MEDICATION USE REMAINS UNKNOWN. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Erosion; Tooth Loss

  MAUDE report 23496098 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD TOOTH #29 (LR5) EXTRACTED. THE PATIENT IS STILL WEARING THE INVISALIGN SYSTEM ALIGNERS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 21746305 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THE PATIENT PRESENTED DIZZINESS, NAUSEA, VOMITING, TREMORS AND SPEECH PROBLEMS. PATIENT WAS HOSPITALIZED FOR 4 DAYS. MEDICAL INTERVENTION AND SYMPTOMS HAPPENED ON (B)(6) 2025. THE PATIENT STOPPED THE USE OF THE PRODUCT AND BY NOW THE PATIENT IS GETTING BETTER.

  Patient problems: Dizziness; Nausea; Shaking/Tremors; Speech Disorder; Vomiting

  MAUDE report 21547316 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED A TOOTH EXTRACTION (TOOTH 2.8), SWOLLEN FACE AND PAIN ON DISTAL SIDE OF THIS TOOTH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema; Tooth Loss

  MAUDE report 21233022 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD AN EXTRACTION OF TOOTH UL7. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 20802162 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT'S TOOTH 3.1/LL1 HAD TO BE EXTRACTED. THIS TOOTH DEVELOPED AN ABSCESS DURING INVISALIGN TREATMENT AND REQUIRED ENDODONTIC TREATMENT, BUT THE CONDITION OF THE TOOTH GOT WORSE, AND THE TOOTH HAD TO BE EXTRACTED.

  Patient problems: Tooth Loss

  MAUDE report 20697629 ↗
• InjuryAug 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF ULCERS ON TONGUE, CHEEK, AND LIPS, THICKENED GUMS, AND WHITE SPOTS ON MUCOSA AND TONGUE. IT WAS REPORTED THAT BACTERIA DEVELOPED UNDER ALIGNER AND THERE WAS AN INFECTION IN THE PATIENT'S JAW AND NERVE, EXTENDING TO THE PATIENT'S RIGHT EAR. THE PATIENT REQUIRED VISITING THE EMERGENCY DOCTOR AT THE HOSPITAL (WHERE THE DOCTOR PERFORMED A ROOT CANAL TREATMENT), A DENTAL HYGIENIST, AND LATER AN ORTHODONTIST. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS FROM THE ROOT CANAL TREATMENT, AND THE PATIENT DISCONTINUED THE USE OF THE ALIGNERS ON (B)(6) 2024.

  Patient problems: Bacterial Infection; Swelling/ Edema; Ulcer

  MAUDE report 19987704 ↗
• InjuryJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOM OF A TOOTH EXTRACTION (TOOTH #6). NO ADDITIONAL INFORMATION OR RECORDS ARE AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 19534444 ↗
• InjuryDec 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOM OF TOOTH EXTRACTION OF TOOTH LL4 AND CERVICAL RESORPTION THAT COULD HAVE WORSENED WITH THE ALIGNERS. 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 18414069 ↗
• InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF TOOTH EXTRACTION AND CROWN DONE (TOOTH UNSPECIFIED; HOWEVER, AFTER REVIEWING RECORDS, THE AFFLICTED TOOTH MAY BE TOOTH #14). IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT TOOK OR WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT IS STILL WEARING THE ALIGNERS.

  Patient problems: Tooth Loss

  MAUDE report 17896021 ↗
• InjuryJun 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF TOOTH #4 MOBILITY AND EXTRACTION. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT IS CONTINUING THE USE OF THE ALIGNERS AND IS CURRENTLY GETTING BETTER.

  Patient problems: Tooth Loss

  MAUDE report 17198084 ↗
• InjuryFeb 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS IS THE FIRST FOLLOW UP REPORT TO 2953749-2023-00484.

  Patient problems: Anaphylactic Shock

  MAUDE report 16329842 ↗
• InjuryFeb 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED PAIN IN UL6 AND UL7 (NON-VITAL TOOTH) AND EXTRACTION OF UL7. THE PAIN DID NOT SUBSIDE AFTER THE EXTRACTION. THE PATIENT REPORTED BEING REFERRED TO A NEUROSURGEON FOR PAIN EVALUATION AND TREATMENT (SUSPECTED TRIGEMINAL NEURALGIA). THE PATIENT REPORTED BEING PRESCRIBED TEGRETOL TO ALLEVIATE THE REPORTED SYMPTOM. THE TREATMENT WAS DISCONTINUED (UNKNOWN DATE), BUT THE CONDITION HAS NOT IMPROVED.

  Patient problems: Tooth Loss

  MAUDE report 16313060 ↗
• InjuryJan 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF LOSS OF DENTAL RESTORATION AND SUPPORTING TEETH. 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 16234937 ↗
• InjuryOct 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF AN ANAPHYLACTIC SHOCK. THE PATIENT REPORTED BEING HOSPITALIZED TO ALLEVIATE THE REPORTED SYMPTOM. THE PATIENT DID NOT REPORT BEING PRESCRIBED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2022 AND THE PATIENT IS CURRENTLY GETTING BETTER.

  Patient problems: Anaphylactic Shock

  MAUDE report 15621089 ↗
• InjuryOct 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED LOSS OF TOOTH #7. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE TE REPORTED SYMPTOM. THE PATIENT REPORTED BEING PRESCRIBED ANTIBIOTICS AND ANTI-INFLAMMATORIES TO ALLEVIATE THE REPORTED SYMPTOM. THE TREATMENT WAS DISCONTINUED ON 04/01/2019, BUT THE CONDITION HAS NOT IMPROVED.

  Patient problems: Tooth Loss

  MAUDE report 15580980 ↗
• InjurySep 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF PAIN, TENDERNESS, MOBILITY, GINGIVAL RECESSION, SWELLING, TOOTH LOSS (PATIENT EXTRACTED TOOTH 2.2 THEMSELF). IT IS UNKNOWN IF THE PATIENT HAS DENTAL TRAUMA, BUT THE TREATING DOCTOR SHARED THAT THEY SUSPECT TRAUMA IN THE AREA. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15462868 ↗