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Digital High Mag®, Green

VOLK OPTICAL INC. · Model VDGTLHM-GN · UDI-DI 00811608012018

HJL
1
510(k) clearances
0
Adverse events
1
Recalls
32
Facilities

Recalls

DateFirmReason
2012-10-25Volk Optical IncThe defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

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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.