# K190965: MyDay

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Apr 29, 2019 after 17 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to P810005 (1981). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131378: Sus (Stenfilcon a) Contact Lens, CooperVision, Inc. (2013) Summary page 4.

## Most influential descendants
- K220070: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (2022), 0 descendants of its own

## Recalls of this device
- Aug 22, 2025 · Class II · Z-2608-2025: One lot manufactured with an invalid sterilization cycle.
- Aug 22, 2025 · Class II · Z-2606-2025: One lot manufactured with an invalid sterilization cycle.
- Aug 22, 2025 · Class II · Z-2607-2025: One lot manufactured with an invalid sterilization cycle.
- Feb 27, 2025 · Class II · Z-1455-2025: a limited number of lots were manufactured with an incorrect cylinder power.

## Indications for use
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

Source page: https://510kreport.com/device/K190965
Methodology: https://510kreport.com/methodology