# K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Jul 26, 2013 after 165 days
- Product code: MVN (Lens, Contact, (Disposable))
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P810005 (1981). 10 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073485: Vistakon (Narafilcon) a Soft Contact Lens, Johnson & Johnson Vision Care, Inc. (2008) Summary page 1.
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 3.
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 1.

## Most influential descendants
- K181920: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2018), 3 descendants of its own
- K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (2024), 1 descendant of its own
- K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (2025), 0 descendants of its own
- K234127: Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (2024), 0 descendants of its own
- K202756: Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (2020), 0 descendants of its own

## Recalls of this device
- Aug 12, 2026 · Class II · Z-3248-2026: A small number of lenses within the affected lot are of the incorrect power.
- May 19, 2021 · Class II · Z-2153-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2149-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2152-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2148-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2147-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2144-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2146-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2154-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2145-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2151-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2150-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- May 19, 2021 · Class II · Z-2143-2021: Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Feb 21, 2018 · Class III · Z-1516-2018: The secondary packaging is labeled with an incorrect expiration date.
- Feb 21, 2018 · Class III · Z-1515-2018: The secondary packaging is labeled with an incorrect expiration date.
- Feb 21, 2018 · Class III · Z-1518-2018: The secondary packaging is labeled with an incorrect expiration date.
- Feb 21, 2018 · Class III · Z-1517-2018: The secondary packaging is labeled with an incorrect expiration date.

## Indications for use
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.

Source page: https://510kreport.com/device/K130331
Methodology: https://510kreport.com/methodology