FDA Device Intelligence
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Lens, Contact, Polymethylmethacrylate, Diagnostic

FDA product code HJK · Class 2 · Ophthalmic

297
Registered devices
9
Adverse events
3
Recalls
41
510(k) clearances

Devices with this code

Recent 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 biob
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.