# K113759: Avaira (Enfilcon a) Contact Lens

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Apr 3, 2012 after 104 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
Longest line of descent: 6 generations back to P810005 (1981). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 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 2.

## Most influential descendants
- K160803: Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (2016), 3 descendants of its own
- K213164: Avaira Vitality (2021), 1 descendant of its own
- K220070: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (2022), 0 descendants of its own
- K182249: Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (2018), 0 descendants of its own
- K133627: Avaira Spheric and Toric (Enfilcon a) Soft Contact Lens (2013), 0 descendants of its own

## Recalls of this device
- Nov 9, 2012 · Class II · Z-0631-2013: The lenses exceeded the acceptance limit for silicone oil residual.

## Indications for use
SPHERICAL AND ASPHERICAL: AVAIRA (enfilcan 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: AVAIRA (en filcon A) Toric Soft Contact lenses are indicated for the correction of anietropia (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: AVAIRA (en f/Icon 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. The AVAIRA (en f/Icon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. The lens may also be prescribed for single-use disposable daily wear.

Source page: https://510kreport.com/device/K113759
Methodology: https://510kreport.com/methodology