Home › METROVISION › Vision Monitor - MonPackONE
Vision Monitor - MonPackONE
METROVISION · Model 2026A · UDI-DI 05060704130019
10
510(k) clearances
11
Adverse events
3
Recalls
38
Facilities
Description
The Vision Monitor MonPackONE system is a non invasive electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals. It can also perform central visual field, pupillometry, dark adaptometry and display optotypes for visual acuity tests. ). It is intended to be used by a healthcare professional in a clinical setting.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-02 | Natus Medical Incorporated | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do |
| 2007-04-02 | Diopsys, Inc. | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. |
| 2004-09-15 | Diopsys Inc | The firm established no medical device quality system, no established quality plan and no established quality procedures. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.