MAUDE Adverse Event Report: CLEARCORRECT, LLC CLEARCORRECT SYSTEM; CLEAR PLASTIC ORTHODONTIC ALIGNER

Lot Number	2232346
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: the complaint was filed and verified the patient is at phase 1 step 1.While reviewing the case it was found the case was opened on (b)(6) 2025, and phase 1 arrived in the customer's office on (b)(6) 2025.There are no photos of the issue and we are currently pending the medical records from the pcp visit.The customer states: "the patient was using step 1, phase 1 aligners for both arches.After wearing the trays for a few days, the symptoms reportedly worsened each day.The patient experienced an allergic-type reaction that included rash, sores, swelling, vomiting, vertigo, and tinnitus.The caller was unsure whether the patient had a fever.No difficulty breathing was reported.The caller was unsure about any known allergies to plastic, and no allergies to disinfectants were reported.The aligners were rinsed before seating and cleaned using only water.The product appeared clean at the time of the report.The patient was evaluated by a primary care physician; however, no specific diagnosis was provided.The reported symptoms included vomiting, vertigo, and tinnitus.To alleviate the reaction, the patient was advised to discontinue aligner use.Medications prescribed included prednisone and meclizine.Clinical evaluation: the complaint is of multi-symptom nature with rash, sores, swelling, vomiting, vertigo and tinnitus.No further detail regarding appearance, location, severity, and resolution, if any, is provided.There is no medical history or clinical examination information or photographs.The patient was evaluated by a primary care physician with no specific diagnosis.It is notable that the aligners were delivered on (b)(6) 2025 and the issue has only recently been reported.Nevertheless, with the lack of details and a physician's inconclusive assessment, no cause-and-effect may be established.There are a number of medical conditions that could explain the patient's symptoms but an association is speculative.As such, this complaint remains inconclusive.
Event or Problem Description
The patient was using step 1, phase 1 aligners for both arches.After wearing the trays for a few days, the symptoms reportedly worsened each day.The patient experienced an allergic-type reaction that included rash, sores, swelling, vomiting, vertigo, and tinnitus.The caller was unsure whether the patient had a fever.No difficulty breathing was reported.The caller was unsure about any known allergies to plastic, and no allergies to disinfectants were reported.The aligners were rinsed before seating and cleaned using only water.The product appeared clean at the time of the report.The patient was evaluated by a primary care physician; however, no specific diagnosis was provided.The reported symptoms included vomiting, vertigo, and tinnitus.To alleviate the reaction, the patient was advised to discontinue aligner use.Medications prescribed included prednisone and meclizine.Photos of the condition were requested, but none were available.The product is available to be returned if needed.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT, LLC; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT, LLC; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; suite 1010; round rock, TX 78665
• MDR Report Key: 25319493
• Report Number: 3007130440-2026-00002
• Device Sequence Number: 5294684
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52708440862337/16D20250926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 2232346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Unknown