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SUPER VIEW® Disposable Lens Set, Pivot

OCULUS SURGICAL INC · Model 40223 · UDI-DI 00856222004742

HJL Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
33
Facilities

Description

1 Each SUPER VIEW® Sterile Disposable Pivot Lens Set for use with the SUPER VIEW® System or BIOM®

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.