Data / Medical devices / United States / Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 11 510(k) clearances and 2 PMA approvals

Name: Johnson & Johnson Vision Care, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Johnson & Johnson Vision Care, Inc. is registered with the FDA (registration 1057985) in Jacksonville, FL, United States. It lists 3 device types. The FDA files 11 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 29, 2021. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Johnson & Johnson Vision Care, Inc.

FDA registration number: 1057985
FEI number: 1000222023
Address: 7500 Centurion Parkway, Jacksonville, FL, United States, 32256
Owner or operator: Johnson & Johnson Vision Care, Inc. (1024871)
Roles: Complaint file establishment, Manufacturer
First device listed: November 27, 2007
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact, (Disposable)	MVN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lenses, Soft Contact, Extended Wear	LPM	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 29, 2021	K210930	ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
March 17, 2020	K200243	ACUVUE (senofilcon A) Soft Contact Lens Multifocal	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
April 10, 2018	K180299	ACUVUE OASYS (senofilcon A) with Photochromic Additive	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
March 28, 2016	K160212	ACUVUE (senofilcon C) Soft Contact Lens	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
September 18, 2014	K141670	ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
March 3, 2008	K073485	VISTAKON (NARAFILCON) A SOFT CONTACT LENS	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
November 1, 2006	K062614	VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)	LPL	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
August 12, 2005	K051900	ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR	MVN	Substantially Equivalent	Johnson & Johnson Vision Care, Inc.	accessdata.fda.gov
October 28, 2004	K042275	VISTAKON (SENOFILCON A) SOFT CONTACT LENS	LPL	Substantially Equivalent	Vistakon	accessdata.fda.gov
February 4, 2004	K033969	ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	Substantially Equivalent	Vistakon	accessdata.fda.gov
February 23, 2000	K994324	ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER	LPL	Substantially Equivalent	Vistakon, Johnson & Johnson Vision Products, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 20, 2005	P040045	VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER	LPM	143	October 16, 2026	accessdata.fda.gov
March 18, 1980	N18033	ACUVUE CONTACT LENS	LPM	107	April 17, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 12, 2025	97095	Class II	Ongoing	ACUVUE OASYS MAX 1-Day MULTIFOCAL	Due to defects (bubbles/voids) identified during standard finished goods testing	accessdata.fda.gov
May 6, 2021	87947	Class II	Terminated	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.	accessdata.fda.gov
March 11, 2019	82402	Class II	Terminated	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.	accessdata.fda.gov
July 23, 2018	80654	Class II	Terminated	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 correcti	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.	accessdata.fda.gov
December 18, 2017	85261	Class II	Terminated	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.	accessdata.fda.gov
October 19, 2017	79152	Class II	Terminated	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.	accessdata.fda.gov
December 21, 2012	64468	Class II	Terminated	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	Limited number of individual contact lens packages may not have been completely sealed.	accessdata.fda.gov
December 1, 2011	60810	Not yet classified	Terminated	Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM*Contact Lenses for Daily WearD -1.50-1.25 1002016/07BC 8.5DIA 14.5Made in USALOT B00BVTN0VS**" I	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.	accessdata.fda.gov
July 16, 2010	56460	Not yet classified	Terminated	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. (	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 Ca	accessdata.fda.gov
April 20, 2009	52828	Not yet classified	Terminated	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 w	Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.