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Contact Lens, HD Professional, Cohen-Benner, "CBC"

OCULUS SURGICAL INC · Model 54013 · UDI-DI 00852475007202

HJK Prescription
1
510(k) clearances
9
Adverse events
3
Recalls
28
Facilities

Description

1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"

Recalls

DateFirmReason
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2016-02-02Volk Optical IncThe firm discovered that the incorrect lot number was engraved on the product.
2015-02-27Volk Optical IncMislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

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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.