Clarity™ Aligners 70000916729Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00652221236609), received between Feb 2, 2023 and Feb 2, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INTRAORAL ITCHINESS AND SWELLING OF THE LIPS WERE REPORTED AFTER USE OF A 3M CLARITY ALIGNER FLEX, SINGLE-ARCH ALIGNER. THE SYMPTOMS BEGAN THE SAME DAY IN THE EVENING AFTER AN ALIGNER WAS WORN. ATTACHMENTS WERE PLACED AT THE ORTHODONTIC CLINIC EARLIER THAT DAY AND NO SYMPTOMS HAD OCCURRED WHEN THE PATIENT HAD LEFT THE ORTHODONTIC OFFICE. THE PATIENT WENT TO THE EMERGENCY ROOM, AN EPINEPHRINE INJECTION WAS ADMINISTERED, THE PATIENT SPENT THE NIGHT FOR OBSERVATION AND WAS DISCHARGED. THE ATTACHMENTS WERE REMOVED ON THE DATE OF DISCHARGE AND NO FURTHER SYMPTOMS OCCURRED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 16287577 ↗