510(k) · Cleared
ClearedAcuvue (Etafilcon a) Soft Contact Lens for Presbyopia
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 Sep 18, 2014 as substantially equivalent to K062614 (Johnson & Johnson Vision Care, Inc., 2006) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Sep 18, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962804 (1996). 16 ancestors in all, the oldest P810005 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 5 generations backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 4 generations backK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- 3 generations backK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- 2 generations backK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
- 1 generation backK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006 · Recalled
- This deviceK141670 Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK211603 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −5 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −4 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| −3 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| −2 | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | 2 |
| −1 | K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted… | Johnson & Johnson Vision Care, Inc. | 2006 | 3 |
| 0 (this device) | K141670 | Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia | Johnson & Johnson Vision Care, Inc. | 2014 | — |
| +1 | K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Summary page 5…Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear most recently cleared via K062614, hereafter also referred to VISTAKON® (etafilcon A); • Optical Design: CIBA VISION i (lotrafilcon B)… | 2006 |
| * | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesSummary page 5…fter also referred to VISTAKON® (etafilcon A); • Optical Design: CIBA VISION i (lotrafilcon B) soft contact lenses cleared via K073459, hereafter also referred to CIBA VISION (lotrafilcon B) i 3rd party trademarks mentioned herein are trademarks of Novarti… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax… | 2022 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K211603 (Pegavision Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062614.
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. 2014, this device’s year, is highlighted.
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?
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 0.75D of astigmatism or less. ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for…
Read the full statement (310 words)
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 0.75D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Tinted, is also indicated for daily wear to enhance or alter the appearance of the eye.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.
When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141670: Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141670
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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