510(k) · Cleared
Recalled · Class II · 2012Avaira (Enfilcon a) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 3, 2012 as substantially equivalent to K071736 (CooperVision, Inc., 2008) after a 104-day review. Its family tree reaches back 6 generations to 1981. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to P810005 (1981). 8 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 2 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 1 generation backK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- This deviceK113759 Avaira (Enfilcon a) Contact LensCooperVision, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK160803 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK213164 Avaira VitalityCooperVision, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK220070 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact…CooperVision, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK182249 Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK133627 Avaira Spheric and Toric (Enfilcon a) Soft Contact LensCooperVision, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · cites it directly3descendants
- K213164Avaira VitalityCooperVision, Inc. · 2021 · 2 generations on1descendant
- K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…CooperVision, Inc. · 2022 · 3 generations on0descendants
- K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated · 2018 · 2 generations on0descendants
- K133627Avaira Spheric and Toric (Enfilcon a) Soft Contact LensCooperVision, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −5 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −4 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −2 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −1 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| 0 (this device) | K113759 | Avaira (Enfilcon a) Contact Lens | CooperVision, Inc. | 2012 | — |
| +1 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | 2016 | 1 |
| +2 | K213164 | Avaira Vitality | CooperVision, Inc. | 2021 | 1 |
| +3 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira… | CooperVision, Inc. | 2022 | 5 |
| +2 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb, Incorporated | 2018 | — |
| +1 | K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact Lens | CooperVision, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensSummary page 2…lens may also be prescribed for single- use disposable daily wear. 6. Predicate Device(s) * COOPERVISION AQUAIR (en filcon A) Soft Contact Lens [K071736] 7. Characteristics of Substantial Equivalence The AVAIRA (enfilcon A) Soft Contact Lens is substantially equivalen… | 2008 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2012 | Class II | Z-0631-2013 | Material/Component Contamination | The lenses exceeded the acceptance limit for silicone oil residual. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K160803 (CooperVision, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K071736.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
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…
Read the full statement (191 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113759: Avaira (Enfilcon a) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113759
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026