Company · US
Johnson & Johnson Vision Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2021. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) Johnson & Johnson Vision Care, Inc. | LPL |
| Mar 17, 2020 | K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal Johnson & Johnson Vision Care, Inc. | LPL |
| Apr 10, 2018 | K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive Johnson & Johnson Vision Care, Inc. | LPL |
| Mar 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens Johnson & Johnson Vision Care, Inc. | LPL |
| Sep 18, 2014 | K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA Johnson & Johnson Vision Care, Inc. | LPL |
| May 21, 2010 | K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER Johnson & Johnson Vision Care, Inc. | LPL |
| Mar 3, 2008 | K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS Johnson & Johnson Vision Care, Inc. | LPL |
| Nov 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) Johnson & Johnson Vision Care, Inc. | LPL |
| Aug 12, 2005 | K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR Johnson & Johnson Vision Care, Inc. | MVN |
| Oct 16, 2003 | K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS Johnson & Johnson Vision Care, Inc. | LPL |
| Jan 22, 2003 | K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER Johnson & Johnson Vision Care, Inc. | LPL |
| Apr 11, 2001 | K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) Johnson & Johnson Vision Care, Inc. | LPL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2025 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS MAX 1-Day MULTIFOCAL Open, Classified |
LPL | K210930 |
| May 6, 2021 | Johnson & Johnson Vision Care, Inc. ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8,
Refractive Power -1.50 Terminated |
LPL | K160212 |
| Apr 11, 2019 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack. Terminated |
LPL | K042275 |
| Jul 23, 2018 | Johnson & Johnson Vision Care, Inc. Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs .
Intended for daily disposable wear Terminated |
LPL | K062614 |
| Dec 18, 2017 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90. Terminated |
MVN | K042275 |
| Oct 19, 2017 | Johnson & Johnson Vision Care, Inc. 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses Terminated |
MVN | K051900 |
| Oct 19, 2017 | Johnson & Johnson Vision Care, Inc. ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR Terminated |
LPL | K032340 |
| Oct 19, 2017 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Terminated |
LPM | K042275 |
| May 17, 2013 | Johnson & Johnson Vision Care, Inc. ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses.
The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia ( Terminated |
LPL | K062614 |
| May 17, 2013 | Johnson & Johnson Vision Care, Inc. 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses.
The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker Terminated |
LPL | K062614 |
| Jan 12, 2012 | Johnson & Johnson Vision Care, Inc. Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA*** Terminated |
MVN | K051900 |