510(k) Report

FDA applicant

Ciba Vision Care

Duluth4 decisions1981–19872 recalls

FDA records 4 decisions for Ciba Vision Care (Duluth) from 1981 to 1987: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes LPM (Lenses, Soft Contact, Extended Wear) and HPX (Lens, Contact (Polymethylmethacrylate)). 2 recalls are 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 Ciba Vision Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ciba Vision Care since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Ciba”

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