510(k) · Cleared
ClearedSoflens Daily Disposable Toric (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, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Jun 10, 2008 as substantially equivalent to K061157 (Bausch & Lomb, 2006) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Jun 10, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K974780 (1998). 6 ancestors in all, the oldest K941370 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 3 generations backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- 2 generations backK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- 1 generation backK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- This deviceK080755 Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted…Bausch & Lomb, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −3 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −2 | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| −1 | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| 0 (this device) | K080755 | Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact LensSummary page 4…6. Description of Safety and Substantial Equivalence A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941 370. Non-Clinical Laboratory Testing: A series of in vitro and in vivo preclinical toxicology and biocompatibil… | 2006 |
| * | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesSummary page 2…Contact Lens cleared in 510(k) Premarket Notification No. K061158 on June 22, 2006, SofLens59 (hilafilcon B) Visibility tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000 and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification No. K9413… | 2000 |
| * | K941370 | Bausch & Lomb Medalist 66 (Alphafilcon a) Visibility Tinted Contact LensSummary page 2…ct Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000 and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification No. K941370 cleared on April 2,1994. The differences between the devices follow.… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K061157.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 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/K080755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080755: Soflens Daily Disposable Toric (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/K080755
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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