# K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Aug 12, 2005 after 30 days
- Product code: MVN (Lens, Contact, (Disposable))
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962804 (1996). 5 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013973: Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted (Visibility and/or Cosmetic) with UV Bloc, Vistakon (2002) Summary page 1.

## Most influential descendants
- K062614: Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) (2006), 7 descendants of its own
- 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
- K141917: Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear (2014), 3 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

## Recalls of this device
- Oct 19, 2017 · Class II · Z-1211-2018: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
- Dec 1, 2011 · Not classified · Z-0734-2012: 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 th

## Indications for use
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.OOD or less of astigmatism. The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less. The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less. The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less. VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye. The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.

Source page: https://510kreport.com/device/K051900
Methodology: https://510kreport.com/methodology