FDA applicant

Ophtec BV

Groningen2 decisions2004–20040 recalls

FDA records 2 decisions for Ophtec BV (Groningen) in 2004: 2 original PMA approvals. Most are in product codes MRJ (Ring, Endocapsular) and MTA (Lens, Intraocular, Phakic). 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 Ophtec BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ophtec BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ophtec”

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

Ophtec USA, Inc. 2

Ophtec BV

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ophtec”