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TOPCON

VISIA IMAGING SRL · Model SOLOS LITE · UDI-DI 08034028770524

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

Description

SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the measurements of spectacles and single lens optical properties

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.