MAIA

CENTERVUE SPA · Model MAIA · UDI-DI 08053677040024

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510(k) clearances

Adverse events

Recalls

Facilities

Description

MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

Recalls

Date	Firm	Reason
2012-08-17	Haag-Streit USA Inc	The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

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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.