FDA applicant

Alcon Surgical, Inc.

Irvine, CA3 decisions1990–19900 recalls

FDA records 3 decisions for Alcon Surgical, Inc. (Irvine, CA) in 1990: 3 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and GEX (Powered Laser Surgical Instrument). 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 Alcon Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alcon Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alcon Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Alcon”

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

Alcon Laboratories 116 Alcon Research, Ltd. 25 Alcon 9 Alcon Manufacturing, Ltd. 6 Alcon Universal, Ltd. 5 Alcon Research, Ltd. Dba Alcon Laboratories, Inc. 2 Alcon Lensx, Inc. 2

Alcon Surgical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Alcon”