Johnson & Johnson Vision Care, Inc.
Jacksonville, FL, US
JOHNSON & JOHNSON VISION CARE, INC. appears in FDA device records in Jacksonville, FL. FDA records list 17 510(k) clearances between and , 2 PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Johnson & Johnson Vision Care, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vistakon510(k), recall
510(k) clearance history
FDA records hold 17 510(k) clearances for Johnson & Johnson Vision Care, Inc. between 2001 and 2021. The busiest year on record is 2001, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | LPL | Substantially Equivalent | |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | LPL | Substantially Equivalent | |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | LPL | Substantially Equivalent | |
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | LPL | Substantially Equivalent | |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | LPL | Substantially Equivalent | |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | MVN | Substantially Equivalent | |
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | |
| K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | |
| K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | |
| K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | |
| K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES | LPL | Substantially Equivalent | |
| K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) | LPL | Substantially Equivalent | |
| K010218 | VISTAKON (HEFILCON C) CONTACT LENSES | LPL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1057985 | 1000222023 | JOHNSON & JOHNSON VISION CARE, INC. | 7500 Centurion Parkway, Jacksonville, FL 32256 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2163-2025 | ACUVUE OASYS MAX 1-Day MULTIFOCAL | Due to defects (bubbles/voids) identified during standard finished goods testing | Class II | Open, Classified | |
| Z-1865-2021 | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50 | Potential that a limited number of individual contact lens packages have an incomplete packaging seal. | Class II | Terminated | |
| Z-1131-2019 | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack. | One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal. | Class II | Terminated | |
| Z-2916-2018 | 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 for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. | Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens. | Class II | Terminated | |
| Z-1744-2020 | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90. | Package integrity failure observed during routine shift package integrity testing at an external re-packager. | Class II | Terminated | |
| Z-1211-2018 | 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. | Class II | Terminated | |
| Z-1210-2018 | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. | Class II | Terminated | |
| Z-1209-2018 | ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. | Class II | Terminated | |
| Z-1336-2013 | 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 (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less. | Limited number of individual contact lens packages may not have been completely sealed. | Class II | Terminated | |
| Z-1335-2013 | 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 for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism. | Limited number of individual contact lens packages may not have been completely sealed. | Class II | Terminated | |
| Z-0734-2012 | 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***LOT B00BVTN0VS***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism. | Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton. | Terminated | ||
| Z-2445-2010 | Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose. | ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper f | Terminated | ||
| Z-2012-2009 | Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process. | Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain