510(k) Report

FDA applicant

Hoya Surgical Optics, Inc.

Chino Hills2 decisions2008–20090 recalls

FDA records 2 decisions for Hoya Surgical Optics, Inc. (Chino Hills) from 2008 to 2009: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HQL (Intraocular Lens) and MSS (Folders And Injectors, Intraocular Lens (Iol)). 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 Hoya Surgical Optics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Hoya Surgical Optics, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Hoya”

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