ClearCorrect System Aligner (Single-Layer)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D865REF00011), received between Aug 26, 2020 and May 12, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER (DENTIST) STATES THE FORCE TO MOVE THE UPPER ANTERIOR TEETH FOR CASE #(B)(4) WAS TOO STRONG CAUSING IRREVERSIBLE PULPITIS ON TOOTH 11 AND 12. DOCTOR HAD TO PERFORM ROOT CANAL THERAPY ON TOOTH 12.

  Patient problems: Nerve Damage

  MAUDE report 11815844 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT CASE #(B)(4) PATIENT IS HAVING AN ALLERGIC REACTION FROM THE PHASE 1 STEP 1 ALIGNERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10838957 ↗
• MalfunctionNov 10, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  PROVIDER: HELLO THERE, I'M REPORTING A SECOND INJURY FOR MY PATIENT#: (B)(6), WHICH IS EVEN LARGER THAN THE FIRST INJURY. THE PATIENT HAD TO SEEK MEDICAL ATTENTION TODAY AS THE ULCER IS EXTREMELY PAINFUL. THIS IS ALIGNER #1 AND THIS IS THE SECOND BATCH. SHE HAD A PREVIOUS INJURY LAST TIME. SHE HAS DECIDED TO DISCONTINUE CLEAR CORRECT AS PER HER MD. I AM VERY EMBARRASSED THIS TIME AND HAVE NO EXCUSE FOR THIS. I'M NOT SURE WHY WE'RE GETTING SO MANY INJURIES THESE DAYS. PLEASE SEND ME A SHIPPING SLIP, I WILL BE SENDING THE ALIGNERS BACK FOR QA TO HAVE A LOOK AT IT, AND CAN WE PROCESS A REFUND FOR THE PATIENT? SHE IS DISCONTINUING HER TREATMENT.

  Patient problems: Ulcer

  MAUDE report 10819940 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATES: I JUST STARTED THIS CASE ON MY PATIENT, AND SHE HAD AN OBVIOUS ALLERGIC REACTION TO THE ALIGNERS AND REQUIRED DISCONTINUATION OF TREATMENT. REACTION PROGRESSED FROM SMALL LOCALIZED ULCERATIONS ON HER LIPS TO LARGER MORE GENERALIZED LESIONS AND SWELLING OF THE LIPS. PATIENT PRESENTED TO HER PHYSICIAN AND WAS DIAGNOSED WITH ALLERGY TO THE ALIGNER MATERIAL AND INSTRUCTED TO REMOVE THEM IMMEDIATELY AND WAS TREATED WITH STEROIDS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10614003 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S LIPS, TONGUE, AND MOUTH SWELLED UP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10610262 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR CALLED AND SAID SHE HAD A LOT OF TROUBLE WITH THE CASE. THE TEETH ARE NOT TRACKING AS HOPED. SHE RESORTED TO USING 2 UPPER TRAYS PER STEP. ON (B)(6), SHE INSERTED TRAY 4 AND THEN THAT NIGHT THE PATIENT TOOK THE TRAY OUT AND THE TOOTH BROKE. ON (B)(6) 2020, A REVISION WAS SUBMITTED. THE RX NOTES SHOW: "TOOTH #24 BROKE FROM THE FORCE OF THE TRAY DURING REMOVAL OF TRAY #4. UPPER TRAY #4 IS NOT WELL SEATED IN ANTERIOR AREA. THERE IS A GAP BETWEEN THE TRAY AND HIS INCISAL EDGES. I HAVE CALLED REPEATEDLY FOR HELP ON THIS CASE AND TRIED THE SUGGESTIONS AND NOTHING IS WORKING. I OPTED TO TAKE NEW IMPRESSIONS TO START OVER. PLEASE SLOW DOWN THE MOVEMENT (MORE TRAYS WITH LESS MOVEMENT BETWEEN STEPS). HE IS AN OLDER PATIENT AND MAXILLARY TEETH ARE NOT MOVING WELL."

  Patient problems: Tooth Fracture

  MAUDE report 10457238 ↗