510(k) · Cleared
ClearedBausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted Contact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Jul 25, 2001 after a 51-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jul 25, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK011718 Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility…Bausch & Lomb, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- Descendant · 2 generations on · 6 of its ownK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- Descendant · 3 generations on · 2 of its ownK200528 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb…Bausch + Lomb, Incorporated · 2020
- Descendant · 4 generations on · 1 of its ownK210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for…Bausch & Lomb, Incorporated · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K061157Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact LensBausch & Lomb · 2006 · cites it directly9descendants
- K113703Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · 2 generations on6descendants
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 3 generations on3descendants
- K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft…Bausch + Lomb, Incorporated · 2020 · 3 generations on2descendants
- K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011718 | Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted… | Bausch & Lomb, Inc. | 2001 | — |
| +1 | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| +2 | K113703 | Bausch + Lomb Nesofilcon a Contact Lens | Bausch & Lomb, Incorporated | 2012 | 1 |
| +3 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| +3 | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)… | Bausch + Lomb, Incorporated | 2020 | — |
| +4 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | 2006 | 9 |
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?
- Of its descendants, K061157 (Bausch & Lomb, 2006) has gone furthest, with 9 descendants of its own.
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 BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011718: Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted Contact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026