# K062614: Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) - Pathway: 510(k) (Special) - Applicant: Johnson & Johnson Vision Care, Inc. - Decided: Nov 1, 2006 after 57 days - Product code: LPL (Lenses, Soft Contact, Daily Wear) - Device class: 2 - Regulation: 21 CFR 886.5925 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K962804 (1996). 8 ancestors in all. 7 later devices descend from it; 3 cite it directly. 0 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear, Johnson & Johnson Vision Care, Inc. (2005) Summary page 1. - K033969: Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker, Vistakon (2004) Summary page 1. ## Most influential descendants - K200296: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (2020), 4 descendants of its own - K211448: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (2021), 2 descendants of its own - K232839: Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (2024), 1 descendant of its own - K141670: Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia (2014), 1 descendant of its own - K253352: Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses (2026), 0 descendants of its own ## Recalls of this device - Jul 23, 2018 · Class II · Z-2916-2018: 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 - Dec 21, 2012 · Class II · Z-1335-2013: Limited number of individual contact lens packages may not have been completely sealed. - Dec 21, 2012 · Class II · Z-1336-2013: Limited number of individual contact lens packages may not have been completely sealed. ## Indications for use The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily 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 non-diseased eyes who may have 1.00D or less of astigmatism. The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 1.00D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The etafilcon A contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. When prescribed for single-use disposable wear (See "Wearing Schedule") the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be discarded after each removal. Source page: https://510kreport.com/device/K062614 Methodology: https://510kreport.com/methodology