510(k) Report

FDA applicant

Addition Technology

Lombard1 decision1999–19990 recalls

FDA records 1 decision for Addition Technology (Lombard) in 1999: 1 original PMA approval. All are in product code LQE (Implant, Corneal, Refractive). 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 Addition Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Addition Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LQEImplant, Corneal, Refractive1decision

What has FDA decided for it lately?

  • P980031Intacs Prescription Inserts/Intacs Corneal ImplantsAddition Technology · 1999

The one decision as Addition Technology →