510(k) · Cleared
Recalled · Class II · 2026Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauflon Pharmaceuticals, Ltd. · MVN Lens, Contact, (Disposable)
Cleared on Jul 26, 2013 as substantially equivalent to K073485 (Johnson & Johnson Vision Care, Inc., 2008) and 2 other predicates after a 165-day review. Its family tree reaches back 5 generations to 1981. 6 later devices descend from it. It has been recalled 17 times.
- Decided
- Jul 26, 2013
- Review
- 165 days
- Class
- Class II
- Product code
- MVN
- Recalls
- 17
- Predicates
- 3
Its longest line of descent runs back 5 generations to P810005 (1981). 10 ancestors in all. 6 later devices descend from it, 3 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 backK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- This deviceK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK181920 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable…CooperVision, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK242413 VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251573 VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK234127 Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily…CooperVision, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK202756 Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A)…CooperVision, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…CooperVision, Inc. · 2018 · cites it directly3descendants
- K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Vizionfocus, Inc. · 2024 · 2 generations on1descendant
- K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc. · 2025 · 3 generations on0descendants
- K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…CooperVision, Inc. · 2024 · 2 generations on0descendants
- K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…CooperVision, Inc. · 2020 · cites it directly0descendants
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 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| 0 (this device) | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable… | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
| +1 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens… | CooperVision, Inc. | 2018 | 1 |
| +2 | K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily… | Vizionfocus, Inc. | 2024 | — |
| +3 | K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | 2025 | — |
| +2 | K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable… | CooperVision, Inc. | 2024 | — |
| +1 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1… | CooperVision, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K073485 | Vistakon (Narafilcon) a Soft Contact LensSummary page 1…antially' equivalent t teAcuivuc Trtieye (Naraflko A) Soft (llydrbphilic) Visibility Tinted Contact Lens for Daily Wear single use. which has been approved pursuant to K073485. and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which hasbeen approved, pursuant… | 2008 |
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 3…s beeni approved pursuant to K(073485, and Air Optik (Loifilcwoh-B),Soft (hydwophilicj Visibility Tinted Contact Lens for Daily Wear which has been approved puirsuantvto K033919/K073459. Thle following table summiarises the primary features for this comparison, illustrating the similarities and dilTerenic… | 2004 |
| * | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesSummary page 1…approved pursuant to K073485. and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which hasbeen approved, pursuant to K03391I9/K073459. 3.- DESCRIPTION of the DEVICE:- The Sauflon Clariti I Day (somnofilco A) Soft (hydrophilic) Daily Disposable Contact Lens with… | 2008 |
What descends from it? (6)
3 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 |
|---|---|---|---|---|
| Aug 12, 2026 | Class II | Z-3248-2026 | Process control | A small number of lenses within the affected lot are of the incorrect power. |
| May 19, 2021 | Class II | Z-2153-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2149-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2152-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2148-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2147-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2144-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2146-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2154-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2145-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2151-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2150-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| May 19, 2021 | Class II | Z-2143-2021 | Equipment maintenance | Misaligned placement of an axis mark can cause the patient to experience blurred vision |
| Feb 21, 2018 | Class III | Z-1516-2018 | Incorrect or no expiration date | The secondary packaging is labeled with an incorrect expiration date. |
| Feb 21, 2018 | Class III | Z-1515-2018 | Incorrect or no expiration date | The secondary packaging is labeled with an incorrect expiration date. |
| Feb 21, 2018 | Class III | Z-1518-2018 | Incorrect or no expiration date | The secondary packaging is labeled with an incorrect expiration date. |
| Feb 21, 2018 | Class III | Z-1517-2018 | Incorrect or no expiration date | The secondary packaging is labeled with an incorrect expiration date. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K181920 (CooperVision, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K073485.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The SAUFLON CLARITI 1-DAY (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1-DAY TORIC (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens…
Read the full statement (288 words)
The SAUFLON CLARITI 1-DAY (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The SAUFLON CLARITI 1-DAY TORIC (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI 1-DAY MULTIFOCAL (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The SAUFLON CLARITI 1-DAY MULTIFOCAL TORIC (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required. Sauflon Clariti 1-Day (somofilcon A)Soft (hydrophilic) Daily Disposable Contact Lenses with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130331 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130331
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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