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Simpli5 3000-0005Recalls & reported problems

Allesee Aoa-Pro · Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth · 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 00889989061918), received between Sep 6, 2017 and Sep 6, 2017 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjurySep 6, 2017Appropriate Device Problem Term/Code Not Available

    DOCTOR ALLEGED PATIENT WORE FIRST TRAY AND DEVELOPED LOCK JAW. PATIENT IS SEEKING MEDICAL TREATMENT.

    Patient problems: No Code Available

    MAUDE report 6847016 ↗

Other Aligner, Sequential devices

All Aligner, Sequential devices →

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