510(k) · Cleared
Recalled · 2006Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · MVN Lens, Contact, (Disposable)
Cleared on May 27, 2005 as substantially equivalent to K963487 (Ciba Vision Corporation, 1996) and 4 other predicates after a 135-day review. Its family tree reaches back 3 generations to 1983. 11 later devices descend from it. It has been recalled once.
- Decided
- May 27, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- MVN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to P820021 (1983). 7 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 2 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 1 generation backK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
- This deviceK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005
- Descendant · cites it directly · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
- Descendant · 2 generations on · 7 of its ownK153643 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK181454 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech…Alcon Laboratories, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK180669 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · cites it directly10descendants
- K153643Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. · 2016 · 2 generations on7descendants
- K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · 3 generations on4descendants
- K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc. · 2018 · 4 generations on2descendants
- K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −2 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −1 | K033701 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft… | Ciba Vision Corporation | 2003 | — |
| 0 (this device) | K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives | Ciba Vision Corporation | 2005 | — |
| +1 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
| +2 | K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016 | — |
| +3 | K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +4 | K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +3 | K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens Our reading of the summary gave K943487, FDA’s number for BIO74-PF Crown & Bridge Alloy (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CIBA Vision's Focus DAILIES (nelfilcon A) One-Day Contact Lens clear…”. | 1996 |
| * | K984273 | Focus Dailies Visitint (Nelfilcon a) One-Day Contact LensSummary page 1…: CIBA Vision's Focus® DAILIES® (nelfilcon A)One-Day Contact Lens Clear lenses (spherical & toric): K943487 VISITINT - lenses: K984273 Manufactudng Change-Surfactant Additive: K010636 Manufacturing Change-Processing Additive: K033701 Multifocal Desig… | 1999 |
| * | K010636 | Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives…Summary page 1…tact Lens Clear lenses (spherical & toric): K943487 VISITINT - lenses: K984273 Manufactudng Change-Surfactant Additive: K010636 Manufacturing Change-Processing Additive: K033701 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon… | 2001 |
| * | K033701 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Summary page 1…K943487 VISITINT - lenses: K984273 Manufactudng Change-Surfactant Additive: K010636 Manufacturing Change-Processing Additive: K033701 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One-Day Visitint lenses:… | 2003 |
| * | K003826 | Focus Dailies ProgressivesSummary page 1…g Change-Processing Additive: K033701 Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One-Day Visitint lenses: K003826 4. Description of Device: The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A)ONE-DAY… | 2001 |
| † | K992446 | Dailies (Nelfilcon a) One-Day | 1999 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | 2009 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2006 | Not classified | Z-1402-06 | Other | Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K083216 (Ciba Vision Corporation, 2009) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K963487.
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?
Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading…
Read the full statement (118 words)
Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.
Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050065: Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050065
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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