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Lens, Fundus, Hruby, Diagnostic

FDA product code HJI · Class 1 · Ophthalmic

5
Registered devices
13
Adverse events
1
Recalls
8
510(k) clearances

Devices with this code

TransEquator (VTE) — VOLK OPTICAL INC.Alcon Grieshaber — Alcon Laboratories, Inc.PDT Laser (VPDT) — VOLK OPTICAL INC.HEINE OMEGA 180 — SONTEC INSTRUMENTS, INC.HEINE OMEGA 180 — SONTEC INSTRUMENTS, INC.

Recent recalls

DateFirmReason
2015-02-27Volk Optical IncMislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring

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