# K131378: Sus (Stenfilcon a) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Aug 30, 2013 after 108 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to P810005 (1981). 10 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens, CooperVision, Inc. (2008) Summary page 1.
- K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens, Ocular Sciences (2002) Summary page 1.

## Most influential descendants
- K160803: Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (2016), 3 descendants of its own
- K191763: MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (2020), 2 descendants of its own
- K223397: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (2024), 1 descendant of its own
- K213164: Avaira Vitality (2021), 1 descendant of its own
- K193399: Miru 1day UpSide (midafilcon A) (2020), 1 descendant 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.
- Dec 27, 2022 · Class II · Z-1014-2023: Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

## Indications for use
Aspherical SUS (stenfilcan A)ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia in aphakic and non-aphakic persons with non-diseased eye in powers from -20.00 D to +20.00 D. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not Interfere with visual acuity. Toric SUS (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. Multifocal SUS (stenflcon 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 0 or less that does not interfere with visual acuity. Multifocal toric SUS (stenflcon A) MULTIFOCAL TORIC Soft Contact Lenses are indicated for the optical correction of distance and near vision in presbyopia phakic or aphakic persons with non-diseased eyes who may have 10.00 D of stigmatism or less.

Source page: https://510kreport.com/device/K131378
Methodology: https://510kreport.com/methodology