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Rexxam

REXXAM CO., LTD. · Model DL-2000 E · UDI-DI 04540008320152

HLM
10
510(k) clearances
5
Adverse events
1
Recalls
66
Facilities

Description

This device intends 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

DateFirmReason
2020-08-06Carl Zeiss Meditec AGDue 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.