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

Lot Number	1860032
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clear correct findings: the information provided states the patient started treatment on (b)(6) 2025.On (b)(6) 2025, while wearing step 2, the patient started experiencing swollen lips.On (b)(6) 2025, the patient went to the emergency room for her symptoms.She was prescribed belozal for the swelling.There has not been a diagnosis given and the patient is scheduled to see an immunologist on (b)(6) 2025.Patient has currently stopped treatment.Allergic reactions are a documented, known undesired side-effect of the clearcorrect system.The occurrences of potential allergic reactions are closely monitored via post-market surveillance, and the trending data indicates no negative impacts, and the occurrence rate is within the expected range.Clinical evaluation: the complaint is of swollen lips following approximately 2 weeks of aligner wear.The patient was seen at an urgent care facility and prescribed belozal.Beyond this, there is no follow up information regarding resolution, clinical examination findings or related medical history.As such this complaint remains inconclusive.Additional information is indicated.
Event or Problem Description
On (b)(6) 2025, the customer contacted clear correct stating their patient was seen at the emergency room due to swollen lips after starting their treatment.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; suite 1010; round rock, TX 78665 ; 8883313323
• MDR Report Key: 23097290
• Report Number: 3007130440-2025-00011
• Device Sequence Number: 9225368
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52703139155517/16D20250801
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/11/2025

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: 1860032
• 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: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 48 YR
• Patient Sex: Unknown