510(k) Report

FDA applicant

Carl Zeiss Meditec Production, LLC

Ontario1 decision2010–20103 recalls

FDA records 1 decision for Carl Zeiss Meditec Production, LLC (Ontario) in 2010: 1 original PMA approval. All are in product code HQL (Intraocular Lens). 3 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 Carl Zeiss Meditec Production, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2015

2011: 22015: 1
2010high 2 (2011) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Carl Zeiss Meditec Production, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Carl”

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