iTero Element Flex 202964Recalls & reported problems

Align Technology, Inc. · Scanner · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816063020295), received between May 10, 2024 and May 10, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Dizziness1
Eye Injury1
Nausea1
Unspecified Ear or Labyrinth Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT REPORTED THE FOLLOWING SYMPTOMS: SEEING BLACK DOTS AND BLACK SQUIGGLY LINES IN VISION, TORN RETINA, NAUSEA, DIZZINESS, IRRITATION, DIFFICULTY SLEEPING, FLUID IN RIGHT EAR AND INFLAMMATION, EYE SORENESS, TINGLING AND ODD SENSATIONS IN THE HEAD, STRESS. TTHE PATIENT REPORTED REQUIRING THE FOLLOWING MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS: CONSULTATIONS WITH NURSE ADVISORS ON (B)(6) 2024, OPHTHALMOLOGIST VISIT (INITIAL VISIT ON (B)(6) 2024 AND FOLLOW UP APPOINTMENT ON (B)(6) 2024), LASER EYE SURGERY (SURGERY PERFORMED (B)(6) 2024), URGENT CARE VISIT ON (B)(6) 2024, NP VISIT ON (B)(6) 2024, CALL WITH OPHTHALMOLOGIST ON (B)(6) 2024 AND (B)(6) 2024, AND VESTIBULAR THERAPY ON (B)(6) 2024. THE PATIENT REPORTED REQUIRING THE FOLLOWING PRESCRIPTION MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOMS: IV, MEDICATION FOR NAUSEA, AND OTC EYE DROPS.
Patient problems: Dizziness; Eye Injury; Nausea; Unspecified Ear or Labyrinth Problem
MAUDE report 19294205 ↗

Device details

UDI-DI	`00816063020295`
Brand	iTero Element Flex
Model	202964
Company	Align Technology, Inc.
Product code	NOF · System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 4, 2023

Device type (GMDN): Dental milling system, CAD/CAM, chairside

An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.

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iTero Element 2 202965
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All System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.