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

Lot Number	1877703
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted clearcorrect on (b)(6) 2025, stating the patient developed a rash in her mouth that spread to her eye.
Additional Manufacturer Narrative
Clear correct findings: a complaint was filed stating "patient had a rash in her mouth that spread up to her eye.The patient is now going to see a dermatologist to find out exactly what she is allergic to.However, the allergy only appeared after she started wearing our aligners." no other information was provided, however, a request for additional information and photos has been sent.No changes have been made to the manufacturing process or materials that would result in potential reactions.Allergic reactions are a documented undesired side-effect of clear aligner therapy which are closely monitored via post-market surveillance.The trending data shows no negative impacts to risk/benefit, and the occurrence rate is within the expected range.Update february 19, 2025: photos of reaction received.Clinical evaluation: the complaint is a sole finding that a rash in the patient's mouth had spread to her eye.No additional information regarding onset, appearance, other signs and symptoms, resolution (if any) was provided.As such, any associations or statements are merely speculative.Common conditions involving rash, redness, irritation from the mouth to eye include herpes outbreaks.It is noted that the patient was referred to a medical expert for consultation.Update (b)(6) 2025: there is mild erythema on the left upper lip and on the tip of the tongue on the left side.Unfortunately, this doesn't contribute much to understanding the situation.If anything, this is more supporting of a herpes simplex outbreak as opposed to an allergic phenomenon through contact with an aligner.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 21572553
• Report Number: 3007130440-2025-00003
• Device Sequence Number: 21067934
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52610030765645/16D20241011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/10/2025

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 Expiration Date: 04/09/2026
• Device Lot Number: 1877703
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (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: 62 YR
• Patient Sex: Female