# K042275: Vistakon (Senofilcon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon
- Decided: Oct 28, 2004 after 66 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 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) Contact Lens: named in the summary without a submission number

## Most influential descendants
- K240477: Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (2024), 2 descendants of its own
- K250364: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (2025), 1 descendant of its own
- K254269: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (2026), 0 descendants of its own
- K210930: ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (2021), 0 descendants of its own
- K200243: ACUVUE (senofilcon A) Soft Contact Lens Multifocal (2020), 0 descendants of its own

## Recalls of this device
- Mar 11, 2019 · Class II · Z-1131-2019: 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.
- Dec 18, 2017 · Class II · Z-1744-2020: Package integrity failure observed during routine shift package integrity testing at an external re-packager.
- Oct 19, 2017 · Class II · Z-1209-2018: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

## Indications for use
The VISTAKON® (senofilcon A)Contact Lens is indicated for daily wear 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® (senofilcon A) Multifocal Contact Lens 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 0.75 D of astigmatism or less. The VISTAKON® (senofilcon A) Toric Contact Lens 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 I0.00 Dof astigmatism or less. The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens 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 10.00 D of astigmatism or less. VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K042275
Methodology: https://510kreport.com/methodology