Cleaning Crystals, Packette 20127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816063021407), received between Oct 11, 2023 and Apr 3, 2025 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Laceration(s)

  MAUDE report 21767116 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATED PATIENT REPORTED PERSISTENT DIFFICULTY CLOSING THE MOUTH, NUMBNESS, TINGLING, AND BURNING IN THE MOUTH AFTER USING THE CLEANING CRYSTALS, THAT HAVE IMPACTED THE ABILITY TO SPEAK, EAT SWALLOW AND WEIGHT LOSS THAT REQUIRED HOSPITALIZATION FOR 4 DAYS ON (B)(6). THESE SYMPTOMS DO NOT APPEAR TO BE LIFE THREATENING TO THE PATIENT. THE PATIENT INDICATED THAT DURING THE HOSPITALIZATION, REQUIRED DIFFERENT MEDICATIONS (NOT CLARIFIED HOW MANY OR WHICH ONES) TO ALLEVIATE THE REPORTED SYMPTOM(S). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aphonia; Burning Sensation; Numbness

  MAUDE report 21740625 ↗
• InjuryOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED SYMPTOMS OF NAUSEA AND BLEEDING WHEN COUGHING DUE TO ACCIDENTALLY INGESTING THE INVISALIGN CLEANING CRYSTALS.THE PATIENT REPORTED REQUIRING A VISIT TO THE EMERGENCY ROOM AND WAS ADMITTED FOR 1 NIGHT TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED OMEPRAZOLE AND ALKALINE SERUM TO ALLEVIATE THE REPORTED SYMPTOMS.THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS ON (B)(6) 2023 AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Nausea

  MAUDE report 17916537 ↗