# K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Jan 4, 2008 after 192 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- 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: 5 generations back to P810005 (1981). 7 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052560: Biofinity (Comfilcon a) Soft Contact Lens, CooperVision, Inc. (2005) Summary page 2.
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 2.

## Most influential descendants
- K131378: Sus (Stenfilcon a) Contact Lens (2013), 10 descendants of its own
- K113759: Avaira (Enfilcon a) Contact Lens (2012), 5 descendants of its own
- 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

## Recalls of this device
- Nov 15, 2011 · Not classified · Z-0350-2012: Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
- Aug 19, 2011 · Not classified · Z-0044-2012: This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy o

## Indications for use
SPHERICAL AND ASPHERICAL: AQUAIR (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) 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. TORIC: AQUAIR (enfilcon 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: AQUAIR (enfilcon A) multifocal 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. DAILY DISPOSABLE: The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for single-use disposable wear. FREQUENT REPLACEMENT: The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Source page: https://510kreport.com/device/K071736
Methodology: https://510kreport.com/methodology