MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN CLEANING CRYSTALS; CLEANSER, DENTURE, OVER THE COUNTER

Model Number	20127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient is currently reporting after putting the "cleaning crystals" product in a glass cup, after 15 minutes went to lift the glass to remove the retainer, the glass cup exploded, shattering into pieces and getting stuck in the hand, face and cheeks.The patient said has used the product already and the instructions for use were followed.The patient confirmed that the glass cup did not have any cracks or defects and was a regular drinking glass cup.No additional information is available at this time.
Additional Manufacturer Narrative
The current indications for use (ifu) contains the following: "aligner/retainer cleaning instructions - remove aligners/retainers and rinse under tap water.Place aligners/retainers into a cleaning container and fill with 100 ml warm water or to fill mark on tub.Add one packet of cleaning crystals.Gently shake/agitate for 20 seconds to dissolve and distribute crystals.Let stand for 15 minutes.Gently shake/agitate again for 20 seconds.Rinse aligners/retainers and container thoroughly with warm water." no conclusive evidence has been provided that supports or opposes whether the invisalign cleaning crystals caused or contributed to the product problem (e,g, defects/malfunctions) and the invisalign cleaning crystals were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.There is no conclusive evidence to confirm the date of the required tooth extraction, and the date (b3) is based on the timelines reported to align and compared to the patient information.

• Brand Name: INVISALIGN CLEANING CRYSTALS
• Common Device Name: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: janier duarte santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 21767116
• Report Number: 2953749-2025-00650
• Device Sequence Number: 8692742
• Product Code: EFT
• UDI-Device Identifier: 00816063021407
• UDI-Public: (01)00816063021407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 20127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female