iFusionRecalls & reported problems
Optovue, Inc. · iVue NR for iFusion USCFG 120V · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jul 27, 2017Terminated
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Z-0009-2018 · Root cause: Other · FDA record ↗
Other Tomography, Optical Coherence devices
- SPECTRALIS 86549Heidelberg Engineering GmbH · Tomography, Optical Coherence1 recall0 reports
- CIRRUS HD-OCT 6000Carl Zeiss Meditec, Inc. · Tomography, Optical Coherence1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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