510(k) Report

510(k) · Cleared

Cleared

Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color)

K010114510(k) TraditionalCleared Apr 11, 200185-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Vision Care, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 11, 2001 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Apr 11, 2001
Review
85 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

24 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2007: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2006: 2 descendants cleared2012: 1 descendant cleared2024: 2 descendants cleared2014: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2017: 2 descendants cleared2021: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK010114 Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted…Johnson & Johnson Vision Care, Inc. · 2001
  2. Descendant · cites it directly · 16 of its ownK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
  3. Descendant · 2 generations on · 14 of its ownK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 9 of its ownK024177 Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens…Johnson & Johnson Vision Care, Inc. · 2003
  5. Descendant · cites it directly · 8 of its ownK033969 Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens…Vistakon · 2004
  6. Descendant · 2 generations on · 7 of its ownK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12006: 22007: 22012: 12014: 22015: 12016: 22017: 22019: 12020: 12021: 12022: 12024: 22025: 12026: 1
2002high 2 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 24 · See all
  • K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon · 2002 · cites it directly16descendants
  • K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Johnson & Johnson Vision Care, Inc. · 2005 · 2 generations on14descendants
  • K024177Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerJohnson & Johnson Vision Care, Inc. · 2003 · cites it directly9descendants
  • K033969Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerVistakon · 2004 · cites it directly8descendants
  • K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc. · 2006 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010114Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or…Johnson & Johnson Vision Care, Inc.2001—
+1K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon2002—
+2K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV…Johnson & Johnson Vision Care, Inc.20052
+1K024177Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV…Johnson & Johnson Vision Care, Inc.2003—
+1K033969Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV…Vistakon2004—
+2K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted…Johnson & Johnson Vision Care, Inc.20063

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200620
200720
201210
201420
201510
201620
201720
201910
202010
202110
202210
202420
202510
202610
FIG. 1 — Lineage of K010114, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon200216
K024177Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerJohnson & Johnson Vision Care, Inc.20039
K033969Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerVistakon20048
K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20072
K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.20071
K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.20160
K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd.20160

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, K013973 (Vistakon, 2002) has gone furthest, with 16 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

More from Johnson & Johnson Vision Care, Inc.

14 FDA decisions under this applicant name. See the company

  • K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. · 20211 recall
  • K200243ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020
  • K180299ACUVUE OASYS (senofilcon A) with Photochromic AdditiveJohnson & Johnson Vision Care, Inc. · 2018
  • K160212ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc. · 20161 recall
  • K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc. · 2014

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K010114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010114

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026