510(k) · Cleared
ClearedSoflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · MVN Lens, Contact, (Disposable)
Cleared on Jun 22, 2006 as substantially equivalent to K974780 (Bausch & Lomb, Inc., 1998) and 2 other predicates after a 57-day review. Its family tree reaches back 3 generations to 1998. 9 later devices descend from it.
- Decided
- Jun 22, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K974780 (1998). 4 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 2 generations backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- 1 generation backK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- This deviceK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- Descendant · cites it directly · 6 of its ownK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- Descendant · 2 generations on · 2 of its ownK200528 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb…Bausch + Lomb, Incorporated · 2020
- Descendant · 3 generations on · 1 of its ownK210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for…Bausch & Lomb, Incorporated · 2021
- Descendant · 2 generations on · 1 of its ownK143632 Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft…Bausch & Lomb, Incorporated · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113703Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · cites it directly6descendants
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 2 generations on3descendants
- K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft…Bausch + Lomb, Incorporated · 2020 · 2 generations on2descendants
- K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated · 2021 · 3 generations on1descendant
- K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −2 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −1 | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| 0 (this device) | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| +1 | K113703 | Bausch + Lomb Nesofilcon a Contact Lens | Bausch & Lomb, Incorporated | 2012 | 1 |
| +2 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| +2 | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)… | Bausch + Lomb, Incorporated | 2020 | — |
| +3 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | 2021 | — |
| +2 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic)… | Bausch & Lomb, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact LensSummary page 1…lity Tinted Contact Lens 3. Predicate Devices: SofLens® one day disposable (hilafilcon A)Visibility Tinted Contact Lens (K974780 and K011718) SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens (K994125) 510(k) PREMARKET NOTIFICATIO… | 1998 |
| * | K011718 | Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted ContactSummary page 1…Contact Lens 3. Predicate Devices: SofLens® one day disposable (hilafilcon A)Visibility Tinted Contact Lens (K974780 and K011718) SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens (K994125) 510(k) PREMARKET NOTIFICATION BAUSCH & L… | 2001 |
| * | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesSummary page 1…SofLens® one day disposable (hilafilcon A)Visibility Tinted Contact Lens (K974780 and K011718) SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens (K994125) 510(k) PREMARKET NOTIFICATION BAUSCH & LOMBW SofLens ® daily disposable (hilafilcon B) Visibility Tinted Contact… | 2000 |
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113703 (Bausch & Lomb, Incorporated, 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K974780.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted 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/K061157
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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