AUTO LENSMETER

NIDEK CO.,LTD. · Model LM-1P · UDI-DI 04987669204979

HLM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Lens measuring instruments / Lensometers This device is designed to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.

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.