510(k) · Cleared
Recalled · Class II · 2018Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Vision Care, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 1, 2006 as substantially equivalent to K051900 (Johnson & Johnson Vision Care, Inc., 2005) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 1, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962804 (1996). 8 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 4 generations backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 3 generations backK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- 2 generations backK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- 1 generation backK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
- This deviceK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
- Descendant · 3 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK141670 Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · cites it directly4descendants
- K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 2 generations on2descendants
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 3 generations on1descendant
- K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc. · 2014 · cites it directly1descendant
- K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −4 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −3 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| −2 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| −1 | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | 2 |
| 0 (this device) | K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted… | Johnson & Johnson Vision Care, Inc. | 2006 | — |
| +1 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
| +2 | K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2021 | — |
| +3 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
| +1 | K141670 | Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia | Johnson & Johnson Vision Care, Inc. | 2014 | — |
| +4 | K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Summary page 1…(hydrophilic) Contact Lens, Clear and Visibility Tinted, with UV Information Blocker for disposable daily wear, most recently cleared via KO051900, 2) ACUVUE®2 COLOURS Brand (etafilcon A) Soft hydrophilic… | 2005 |
| * | K033969 | Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSummary page 1…con A) Soft hydrophilic Contact Lens With UV Blocker for Daily Wear most recently cleared via K033969. Continued on next page Special 51… | 2004 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2018 | Class II | Z-2916-2018 | Equipment maintenance | Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the… |
| Dec 21, 2012 | Class II | Z-1335-2013 | Packaging | Limited number of individual contact lens packages may not have been completely sealed. |
| Dec 21, 2012 | Class II | Z-1336-2013 | Packaging | Limited number of individual contact lens packages may not have been completely sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K200296 (Pegavision Corporation, 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K051900.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL…
Read the full statement (416 words)
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 1.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The etafilcon A contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
When prescribed for single-use disposable wear (See "Wearing Schedule") the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062614: Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062614
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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