FDA applicant
Johnson & Johnson Vision Care, Inc.
FDA records 13 decisions for Johnson & Johnson Vision Care, Inc. (Jacksonville, FL) from 2001 to 2021: 12 510(k) clearances and 1 original PMA approval. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and MVN (Lens, Contact, (Disposable)). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 5 of them its own earlier devices. 8 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 Vision Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Johnson & Johnson Vision Care, 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.