510(k) Report

510(k) · Cleared

Cleared

DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

K172066510(k) SpecialCleared Aug 9, 201733-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

Alcon Laboratories, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Aug 9, 2017 after a 33-day review. The FDA summary names no predicate by number. 6 later devices descend from it.

Decided
Aug 9, 2017
Review
33 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2018: 3 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared201620182020202220242026
  1. This deviceK172066 DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric…Alcon Laboratories, Inc. · 2017
  2. Descendant · cites it directly · 4 of its ownK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
  3. Descendant · cites it directly · 2 of its ownK181454 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech…Alcon Laboratories, Inc. · 2018
  4. Descendant · cites it directly · 2 of its ownK180669 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
  5. Descendant · 2 generations on · 0 of its ownK202448 DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP…Alcon Laboratories, Inc. · 2020
  6. Descendant · 2 generations on · 0 of its ownK202036 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 32019: 12020: 2
2018high 3 (2018) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · cites it directly4descendants
  • K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc. · 2018 · cites it directly2descendants
  • K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · cites it directly2descendants
  • K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc. · 2020 · 2 generations on0descendants
  • K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K172066DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES…Alcon Laboratories, Inc.2017—
+1K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES…Alcon Laboratories, Inc.2018—
+1K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES…Alcon Laboratories, Inc.2018—
+1K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES…Alcon Laboratories, Inc.2018—
+2K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.2020—
+2K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES…Alcon Laboratories, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201830
201910
202020
FIG. 1 — Lineage of K172066, 2017–2020Source: 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), 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. #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?

The FDA summary names no predicate by number.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20184
K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc.20182
K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20182

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, K180398 (Alcon Laboratories, Inc., 2018) has gone furthest, with 4 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. 2017, this device’s year, is highlighted.

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 Alcon Laboratories, Inc.

489 FDA decisions under this applicant name. See the company

  • P930014/S164AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P930014/S163Acrosof Posterior Chamber Intraocular LensAlcon Laboratories, Inc. · 2026
  • P930014/S165AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P010019/S087Focus Night and Day (Lotrafilcon a) Soft Contact LensesAlcon Laboratories, Inc. · 2026
  • P930014/S161AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL…Alcon Laboratories, Inc. · 2026

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/K172066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172066: DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172066

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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