ALM500

ESSILOR INTERNATIONAL · Model ALM500 · UDI-DI 03615020000038

510(k) clearances

Adverse events

Recalls

Facilities

Description

This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis

Recalls

Date	Firm	Reason
2020-08-06	Carl Zeiss Meditec AG	Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety

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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.