FDA applicant
Alcon Research, Ltd.
FDA records 25 decisions for Alcon Research, Ltd. (Fort Worth, TX) from 1985 to 2024: 17 510(k) clearances and 8 original PMA approvals. Most are in product codes HQC (Unit, Phacofragmentation) and LPO (Gases Used Within Eye To Place Pressure On…). Its devices cite 36 predicates, 10 of them its own earlier devices. 22 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Alcon Research, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alcon Research, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
5in 2025
Class I Class II/III not classified
Planning a device like Alcon Research, Ltd.’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.