510(k) · Cleared
ClearedFocus Dailies Visitint (Nelfilcon a) One-Day Contact Lens
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 Jan 25, 1999 after a 56-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Jan 25, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK984273 Focus Dailies Visitint (Nelfilcon a) One-Day Contact LensCiba Vision Corporation · 1999
- Descendant · cites it directly · 22 of its ownK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- Descendant · cites it directly · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- Descendant · cites it directly · 12 of its ownK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
- Descendant · cites it directly · 11 of its ownK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · Recalled
- Descendant · 2 generations on · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999 · cites it directly22descendants
- K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · cites it directly21descendants
- K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation · 2003 · cites it directly12descendants
- K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · cites it directly11descendants
- K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984273 | Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens | Ciba Vision Corporation | 1999 | — |
| +1 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| +1 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| +1 | K033701 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft… | Ciba Vision Corporation | 2003 | — |
| +1 | K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives | Ciba Vision Corporation | 2005 | 1 |
| +2 | K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Ciba Vision Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Focus® DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS Named without a submission number |
What descends from it? (25)
See all 254 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?
- Of its descendants, K992446 (Ciba Vision Johns Creek Mfg., 1999) has gone furthest, with 22 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?
Focus® DAILIES® Visitint® (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® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use daily disposable wear. Focus® DAILIES® Visitint® LENSES are not intended to be cleaned or disinfected and should be discarded after…
Read the full statement (149 words)
Focus® DAILIES® Visitint® (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® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use daily disposable wear. Focus® DAILIES® Visitint® LENSES are not intended to be cleaned or disinfected and should be discarded after a single use.
Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia in not-aphakic persons with non-diseased eyes who are myopic or hyperopic and may have minimal astigmatism that does not interfere with visual acuity.
Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use daily disposable wear. Focus® DAILIES® Visitint® LENSES are not intended to be cleaned or disinfected and should be discarded after a single use.
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/K984273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984273: Focus Dailies Visitint (Nelfilcon a) One-Day 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/K984273
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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