Johnson & Johnson Vision Care, Inc.
FDA Regulatory Profile
Johnson & Johnson Vision Care, Inc. appears in FDA public data with 10 recalls, 12 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2163-2025, Class II) was initiated on Jun 12, 2025. Its most recent 510(k) clearance was granted on Nov 29, 2021.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 12
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2163-2025 | Class II | ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL | Jun 12, 2025 |
| Z-1865-2021 | Class II | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive | May 6, 2021 |
| Z-1131-2019 | Class II | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x | Mar 11, 2019 |
| Z-2916-2018 | Class II | Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master L | Jul 23, 2018 |
| Z-1744-2020 | Class II | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Powe | Dec 18, 2017 |
| Z-1211-2018 | Class II | 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses | Oct 19, 2017 |
| Z-1209-2018 | Class II | ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS | Oct 19, 2017 |
| Z-1210-2018 | Class II | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR | Oct 19, 2017 |
| Z-1336-2013 | Class II | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistako | Dec 21, 2012 |
| Z-1335-2013 | Class II | 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon | Dec 21, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | Nov 29, 2021 |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Mar 17, 2020 |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | Apr 10, 2018 |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Mar 28, 2016 |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | Sep 18, 2014 |
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | May 21, 2010 |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | Mar 3, 2008 |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC | Nov 1, 2006 |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Aug 12, 2005 |
| K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | Oct 16, 2003 |
| K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Jan 22, 2003 |
| K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IR | Apr 11, 2001 |