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Synergy ODM 4.06Recalls & reported problems

Topcon Healthcare Inc · Synergy ODM 4.06 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00852683007018), received between Nov 28, 2022 and Nov 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Data Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Data Problem1

Patient problems

  • Insufficient Information1
  • Unspecified Eye / Vision Problem1

Recent adverse event reports

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

  • InjuryNov 28, 2022Data Problem; Data Problem

    THE PATIENT UNDERWENT A CORRECTIVE SURGERY TO HAVE THEIR BILATERAL LENSES REPLACED WITH THOSE OF THE CORRECT PRESCRIPTION. THIS CORRECTIVE SURGERY OCCURRED THE DAY AFTER THE INITIAL INCIDENT, AND NO POST-OPERATION ISSUES HAVE BEEN REPORTED SINCE THEN.

    Patient problems: Insufficient Information; Unspecified Eye / Vision Problem

    MAUDE report 15869003 ↗

Other System, Image Management, Ophthalmic devices

All System, Image Management, Ophthalmic devices →

Sources and updates

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