FDA applicant
Johnson & Johnson Surgical Vision, Inc.
FDA records 11 decisions for Johnson & Johnson Surgical Vision, Inc. (Irvine) from 1983 to 2023: 4 510(k) clearances and 7 original PMA approvals. Most are in product codes HQL (Intraocular Lens) and LZP (Aid, Surgical, Viscoelastic). Its devices cite 6 predicates, 0 of them its own earlier devices. 47 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Johnson & Johnson Surgical Vision, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Johnson & Johnson Surgical Vision, 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) ReportOther applicant names beginning “Johnson”
FDA records each applicant name separately; these may or may not be the same firm.