510(k) · Cleared
Recalled · Class II · 2017Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Vision Care, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Aug 12, 2005 as substantially equivalent to K013973 (Vistakon, 2002) after a 30-day review. Its family tree reaches back 4 generations to 1996. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 12, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- MVN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962804 (1996). 5 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 3 generations backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 2 generations backK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- 1 generation backK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- This deviceK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
- Descendant · cites it directly · 3 of its ownK141917 Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker…Unicon Optical Co., Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
- Descendant · 4 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc. · 2006 · cites it directly7descendants
- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 2 generations on4descendants
- K141917Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearUnicon Optical Co., Ltd. · 2014 · cites it directly3descendants
- K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 3 generations on2descendants
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −3 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −2 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| −1 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| 0 (this device) | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | — |
| +1 | K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted… | Johnson & Johnson Vision Care, Inc. | 2006 | 3 |
| +2 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
| +1 | K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily… | Unicon Optical Co., Ltd. | 2014 | — |
| +3 | K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2021 | — |
| +4 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Summary page 1…VUE® Brand (etafilcon A) Device Contact Lens, Clear and Visibility Tinted, with UV Blocker for Information disposable daily wear most recently cleared via K013973. Device The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear Description and Visibility Tinted wit… | 2002 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility… | 2006 | 7 |
| K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear | 2014 | 3 |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking… | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2017 | Class II | Z-1211-2018 | Packaging process control | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. |
| Dec 1, 2011 | Not classified | Z-0734-2012 | Employee error | Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062614 (Johnson & Johnson Vision Care, Inc., 2006) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K013973.
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 VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.OOD or less of astigmatism. The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for…
Read the full statement (275 words)
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.OOD or less of astigmatism.
The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051900 · printed Nov 3, 2026
Cite this page
510(k) Report. “K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K051900
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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