510(k) Report

FDA applicant

Eyetech, LLC

Chicago, IL2 decisions1984–19900 recalls

FDA records 2 decisions for Eyetech, LLC (Chicago, IL) from 1984 to 1990: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HKX (Tonometer, Ac-Powered) and HQL (Intraocular Lens). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Eyetech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eyetech, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eyetech, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Eyetech”

FDA records each applicant name separately; these may or may not be the same firm.