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Paradigm

Kenmark Optical, Inc. · Model 2055FO55 · UDI-DI 00715317069823

HQY
10
510(k) clearances
50
Adverse events
1
Recalls
1,432
Facilities

Description

20-55 Forest (Polarized) Spectacle

Recalls

DateFirmReason
2009-11-24LuxotticaThe lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness rang

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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.