FDA applicant
Alcon
FDA records 9 decisions for Alcon (Fort Worth, TX) from 1983 to 2008: 5 510(k) clearances and 4 original PMA approvals. Most are in product codes HQL (Intraocular Lens) and LPN (Accessories, Soft Lens Products). Its devices cite 9 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Alcon, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alcon’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
11in 2010
Class I Class II/III not classified
Planning a device like Alcon’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) ReportOther applicant names beginning “Alcon”
FDA records each applicant name separately; these may or may not be the same firm.