iVueRecalls & reported problems across all models
Optovue, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of iVue by Optovue, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
iVue recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 27, 2017Terminated
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Z-0008-2018 · Root cause: Other · names 3 of these models · Recall details · FDA record ↗
iVue models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iVue iVue 100-1Ophthalmoscope, Ac-Powered1 recall0 reports
- iVue iVue 100Ophthalmoscope, Ac-Powered1 recall0 reports
- iVue iVue 100-1Ophthalmoscope, Ac-Powered1 recall0 reports
Other Optovue, Inc. products
All Optovue, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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