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Vision Monitor - MonCvONE

METROVISION · Model 2026A · UDI-DI 05060704130002

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, spectra and topographic maps. ). 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.

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Data 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.