INVISALIGN CLEANING CRYSTALS
Received Apr 3, 2025 · Event occurred Mar 1, 2025
Report 2953749-2025-00650 · MDR key 21767116
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
35 YR · Female
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or 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.
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.