FDA applicant

Brien Holden Vision Pty, Ltd.

Sydney, AU1 decision2015–20150 recalls

FDA records 1 decision for Brien Holden Vision Pty, Ltd. (Sydney, AU) in 2015: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Brien Holden Vision Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Brien Holden Vision Pty, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Brien Holden Vision Pty, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?