510(k) · Cleared
Recalled · Class II · 2025MyDay
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 29, 2019 as substantially equivalent to K131378 (CooperVision, Inc., 2013) after a 17-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Apr 29, 2019
- Review
- 17 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to P810005 (1981). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 2 generations backK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- 1 generation backK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · Recalled
- This deviceK190965 MyDayCooperVision, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK220070 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact…CooperVision, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…CooperVision, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −6 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −5 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −4 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −3 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −2 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| −1 | K131378 | Sus (Stenfilcon a) Contact Lens | CooperVision, Inc. | 2013 | 5 |
| 0 (this device) | K190965 | MyDay | CooperVision, Inc. | 2019 | — |
| +1 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira… | CooperVision, Inc. | 2022 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131378 | Sus (Stenfilcon a) Contact LensSummary page 4…lassification Panel: Ophthalmic III. PREDICATE DEVICE: CooperVision’s SUS (stenfilcon A) Soft (hydrophilic) Contact Lenses for Single Use Daily Wear, K131378 IV. DEVICE DESCRIPTION: MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2025 | Class II | Z-2608-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Aug 22, 2025 | Class II | Z-2606-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Aug 22, 2025 | Class II | Z-2607-2025 | Under Investigation by firm | One lot manufactured with an invalid sterilization cycle. |
| Feb 27, 2025 | Class II | Z-1455-2025 | Process control | a limited number of lots were manufactured with an incorrect cylinder power. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K220070 (CooperVision, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131378.
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. 2019, 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?
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or…
Read the full statement (185 words)
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (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.
MyDay (stenfilcon 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 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190965: MyDay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190965
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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