# K032340: Vistakon (Galyfilcon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Oct 16, 2003 after 79 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Focus NIGHT AND DAY (lotrafilcon A): named in the summary without a submission number

## Most influential descendants
- K073485: Vistakon (Narafilcon) a Soft Contact Lens (2008), 30 descendants of its own
- K100349: Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker (2010), 13 descendants of its own
- K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric (2012), 12 descendants of its own
- K160344: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 (2016), 8 descendants of its own
- K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2013), 6 descendants of its own

## Recalls of this device
- Oct 19, 2017 · Class II · Z-1210-2018: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

## Indications for use
The VISTAKON®(galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.OOD or less of astigmatism. The VISTAKON®(galyfilcon A) Multifocal Contact Lens 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®(galyfilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less. The VISTAKON* (galyfilcon A) Toric-Multifocal Contact Lens 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®(galyfilcon A) UV Blocking Contact Lenses help protect against transmission of harmful W radiation to the cornea and into the eye. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequenuplanned replacement wear with cleaning, disinfection and scheduled replacement (see “Wearing Schedule”). When prescribed for frequenuplanned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K032340
Methodology: https://510kreport.com/methodology