Invisalign 1011Recalls & reported problems
Align Technology, Inc. · Invisalign Retainer · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816063020011), received between Jan 18, 2024 and Mar 13, 2026 — classified as 4 injuries.
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 Problem2
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Tooth Loss4
- Tooth Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED SYMPTOMS OF ONE DENTAL CROWN BECOMING COMPLETELY DISLODGED, INCLUDING THE PIN SECURING IT, AND A SECOND CROWN BECOMING DAMAGED WHILE ATTEMPTING TO SEAT OR REMOVE AN INVISALIGN RETAINER. THE PATIENT REPORTED VISITING THE TREATING DOCTOR AND REQUIRED MEDICAL INTERVENTION CONSISTING OF REPLACEMENT OF THE BROKEN CROWN, A BONE GRAFT, AND A FUTURE IMPLANT PLACEMENT, MEANING THAT THE PATIENT AT SOME POINT LOST A TOOTH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT WERE UNSUCCESSFUL.
Patient problems: Tooth Loss
MAUDE report 24597429 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TOOTH FRACTURE REQUIRING EXTRACTION AND BRIDGE PLACEMENT. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTION OR MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS BEYOND THE PRESCRIBED TYLENOL. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED.
Patient problems: Tooth Fracture; Tooth Loss
MAUDE report 23646500 ↗InjuryApr 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE TREATING DOCTOR REPORTED PATIENT PRESENTS TOOTH MOBILITY AND WILL REQUIRE TOOTH EXTRACTION OF TOOTH #9. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Tooth Loss
MAUDE report 21920625 ↗InjuryJan 18, 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 ISSUES WITH THE UPPER FOUR FRONT TEETH (TOOTH MOBILITY AND TEETH STARTED FALLING OUT). THE PATIENT REPORTED THAT THE PATIENT IS IN PROCESS FOR IMPLANTS FOR THE UPPER FOUR FRONT TEETH AND IMPLANTS ARE PLANNED FOR NEXT MONTH. 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 RETAINERS.
Patient problems: Tooth Loss
MAUDE report 18536050 ↗
Other Maintainer, Space Preformed, Orthodontic devices
- Vivera 8579Align Technology, Inc. · Maintainer, Space Preformed, Orthodontic13 reports
- Vivera Realine 8567Align Technology, Inc. · Maintainer, Space Preformed, Orthodontic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.