510(k) Report

FDA applicant

Vistakon, Division of Johnson & Johnson Vision Car

Jacksonville1 decision2005–20051 recall

FDA records 1 decision for Vistakon, Division of Johnson & Johnson Vision Car (Jacksonville) in 2005: 1 original PMA approval. All are in product code LPM (Lenses, Soft Contact, Extended Wear). 1 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 Vistakon, Division of Johnson & Johnson Vision Car’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vistakon, Division of Johnson & Johnson Vision Car since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vistakon, Division of Johnson & Johnson Vision Car by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Vistakon”

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