510(k) · Cleared
Recalled · 2011Aquair (Enfilcon a) Soft (Hydrophilic) 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 Jan 4, 2008 as substantially equivalent to K052560 (CooperVision, Inc., 2005) and 1 other predicate after a 192-day review. Its family tree reaches back 5 generations to 1981. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 4, 2008
- Review
- 192 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to P810005 (1981). 7 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 5 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 4 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 3 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 2 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 1 generation backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- This deviceK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · Recalled
- Descendant · cites it directly · 5 of its ownK113759 Avaira (Enfilcon a) Contact LensCooperVision, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK160803 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191763 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay…CooperVision, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · cites it directly10descendants
- K113759Avaira (Enfilcon a) Contact LensCooperVision, Inc. · 2012 · cites it directly5descendants
- K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc. · 2016 · 2 generations on3descendants
- K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…CooperVision, Inc. · 2020 · 2 generations on2descendants
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −4 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −3 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −2 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −1 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| 0 (this device) | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | — |
| +1 | K131378 | Sus (Stenfilcon a) Contact Lens | CooperVision, Inc. | 2013 | 5 |
| +1 | K113759 | Avaira (Enfilcon a) Contact Lens | CooperVision, Inc. | 2012 | 1 |
| +2 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | 2016 | 1 |
| +2 | K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)… | CooperVision, Inc. | 2020 | — |
| +3 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 2…systems. The lens may also be prescribed for single-use disposable daily wear. 6. Predicate Device(s) * COOPERVISION BIOFINITY (comfilcon A) Soft Contact Lenses [K052560] - CIBA Vision O2OPTIXTM (lotrafilcon B) Soft Contact Lenses [K033919]… | 2005 |
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 2…wear. 6. Predicate Device(s) * COOPERVISION BIOFINITY (comfilcon A) Soft Contact Lenses [K052560] - CIBA Vision O2OPTIXTM (lotrafilcon B) Soft Contact Lenses [K033919] - 2 - CooperVismo… | 2004 |
What descends from it? (14)
See all 144 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 15, 2011 | Not classified | Z-0350-2012 | Process control | Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses. |
| Aug 19, 2011 | Not classified | Z-0044-2012 | Material/Component Contamination | 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 or blurry vision and discomfort, most… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K131378 (CooperVision, Inc., 2013) has gone furthest, with 10 descendants of its own.
- 14 other devices also cite its predicate K052560.
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. 2008, 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: 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…
Read the full statement (195 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071736 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071736
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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