Johnson & Johnson Vision Care, Inc.

• ACUVUE OASYS MAX Contact Lenses Ref Many

  Class IIa EUDAMED Active

• ACUVUE 2 Brand Contact Lenses Ref Many

  Class IIa EUDAMED Active

• 1-DAY ACUVUE DEFINE Brand Contact Lenses with LACREON Ref Many

  Class IIa EUDAMED Active

• Acuvue Oasys Multifocal Ref Many

  Class IIa EUDAMED Active

• ACUVUE VITA Brand Contact Lenses for Astigmatism Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Ref Many

  Class IIa EUDAMED Active

• ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management Ref Many

  Class IIa EUDAMED Active

• 1-DAY ACUVUE MOIST Brand Contact Lenses with LACREON for ASTIGMATISM Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS MAX 1-Day MULTIFOCAL Contact Lenses Ref Many

  Class IIa EUDAMED Active

• 1-DAY ACUVUE MOIST Brand Contact Lenses with LACREON Ref Many

  Class IIa EUDAMED Active

• 1-DAY ACUVUE MOIST Brand Contact Lenses with LACREON Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS Brand Contact Lenses with HydraLuxe Ref Many

  Class IIa EUDAMED Active

• 1-DAY ACUVUE MOIST Brand MULTIFOCAL Contact Lenses with LACREON Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS Brand Contact Lenses with HydraLuxe Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS Brand Contact Lenses with HydraLuxe for ASTIGMATISM Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS MAX 1-Day MULTIFOCAL Contact Lenses for Astigmatism Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS MAX 1-Day for ASTIGMATISM Contact Lenses Ref Many

  Class IIa EUDAMED Active

• ACUVUE VITA Brand Contact Lenses Ref Many

  Class IIa EUDAMED Active

• ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Ref Many

  Class IIa EUDAMED Active

• Acuvue 2 Colours Brand (Etafilcon A) Soft (Hydrophilic) Contact Lens With Uv Blocker Ref K024177

  Class II FDA 510(k) Active

• Vistakon (Narafilcon B) Contact Lens Visibility Tinted With Uv Blocker Ref K100349

  Class II FDA 510(k) Active

• Acuvue (Etafilcon A) Soft Contact Lens For Presbyopia Ref K141670

  Class II FDA 510(k) Active

• Vistakon (Etafilcon A) Soft (Hydrophilic) Contact Lens, Clear And Tinted (Visibility And/Or Cosmetically) Ref K062614

  Class II FDA 510(k) Active

• Vistakon (Galyfilcon A) Soft Contact Lens Ref K032340

  Class II FDA 510(k) Active

• ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) Ref K210930

  Class II EUDAMEDFDA 510(k) Active

• Vistakon (Narafilcon) A Soft Contact Lens Ref K073485

  Class II FDA 510(k) Active

• ACUVUE OASYS (senofilcon A) with Photochromic Additive Ref K180299

  Class II FDA 510(k) Active

• Acuvue 2 Brand (Etafilcon A) Contact Lens, With Uv Blocker Tinted (To Mask Or Enhance The Natural Iris Color) Ref K010114

  Class II FDA 510(k) Active

• Acuvue (Etafilcon A) Contact Lens, Clear And With Visibility Tint With Uv Blocker, For Daily Wear Ref K051900

  Class II FDA 510(k) Active

• ACUVUE (senofilcon C) Soft Contact Lens Ref K160212

  Class II FDA 510(k) Active

• ACUVUE (senofilcon A) Soft Contact Lens Multifocal Ref K200243

  Class II FDA 510(k) Active

• Vistakon (Lenefilcon A) Soft (Hydrophilic) Contact Lens, Clear And Visibility Tinted With Uv Blocker Ref K994318

  Class III FDA PMA Active

Showing the 10 most recent of 11 recalls.

• 2025

  • 12 Jun 2025 Z-2163-2025 Class II Ongoing Due to defects (bubbles/voids) identified during standard finished goods testing

• 2021

  • 6 May 2021 Z-1865-2021 Class II Terminated Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

• 2019

  • 11 Mar 2019 Z-1131-2019 Class II Terminated 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.

• 2018

  • 23 Jul 2018 Z-2916-2018 Class II Terminated 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.

• 2017

  • 18 Dec 2017 Z-1744-2020 Class II Terminated Package integrity failure observed during routine shift package integrity testing at an external re-packager.
  • 19 Oct 2017 Z-1209-2018 Class II Terminated Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • 19 Oct 2017 Z-1210-2018 Class II Terminated Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • 19 Oct 2017 Z-1211-2018 Class II Terminated Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

• 2012

  • 21 Dec 2012 Z-1335-2013 Class II Terminated Limited number of individual contact lens packages may not have been completely sealed.
  • 21 Dec 2012 Z-1336-2013 Class II Terminated Limited number of individual contact lens packages may not have been completely sealed.

Country

United States(from SRN)

Address

7500, Centurion Parkway, Florida, United States

Website

www.jjvision.com/

Facebook

facebook.com/JnJVision

Email

[email protected]

Phone

+1 (904) 443-3600

PRRC contact

Maria Alexandra Romero

EUDAMED SRN

US-MF-000038719

FDA FEI number

1000222023