510(k) Report

510(k) · Cleared

Cleared

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

K162597510(k) SpecialCleared Oct 19, 201630-day reviewClass II21 CFR 886.5928

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

Alcon Laboratories, Inc. · LPN Accessories, Soft Lens Products

Cleared on Oct 19, 2016 as substantially equivalent to K003345 (Ciba Vision Corporation, 2001) and 6 other predicates after a 30-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.

Decided
Oct 19, 2016
Review
30 days
Class
Class II
Product code
LPN
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K003345 (2001). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors2002: 1 other ancestor2017: 1 descendant cleared2019: 1 descendant clearedK003345 · Aosept Plus Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001K013512 · Aosept Clear Care Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants K013512 · Aosept Clear Care Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001K003345 · Aosept Plus Cleaning and Disinfecting Solution · Ciba Vision Corporation · 20010
  1. Root · 2 generations backK003345 Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
  2. 1 generation backK013512 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
  3. This deviceK162597 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2016
  4. Descendant · cites it directly · 1 of its ownK173538 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2017
  5. Descendant · cites it directly · 0 of its ownK191795 AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017 · cites it directly1descendant
  • K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003345Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation2001—
−1K013512Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation2001—
0 (this device)K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.2016—
+1K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.2017—
+1K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
FIG. 1 — Lineage of K162597, 2001–2019Source: 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 LPN? 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 LPN device

  1. #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*P820040Septicon (TM) Disinfection Regimen for Use with
FDA lists this PMA only through its supplements; the earliest we hold is P820040/S001 (Dec 23, 1983).
Summary page 5
…device(s) to which we are claiming substantial equivalence are: 510(k) Number Device Previously approved in AOCup Lens Case with AODisc PMA P820040, Supplement S032, 23-Oct- 1995 (Reclassified to Class II in 1997) K003345, 26-Mar-2001; Clear Care Cleaning & Dis…
Ciba Vision Care—
*K003345Aosept Plus Cleaning and Disinfecting Solution
Summary page 5
…Device Previously approved in AOCup Lens Case with AODisc PMA P820040, Supplement S032, 23-Oct- 1995 (Reclassified to Class II in 1997) K003345, 26-Mar-2001; Clear Care Cleaning & Disinfecting Solution (contains the AOCup Lens Case…
Ciba Vision Corporation2001—
*K013512Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…7) K003345, 26-Mar-2001; Clear Care Cleaning & Disinfecting Solution (contains the AOCup Lens Case with AODisc as part of the K013512, 20-Dec-2001; system) K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; K031521, 27-Jun-2003…
Ciba Vision Corporation2001—
*K022687Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…Care Cleaning & Disinfecting Solution (contains the AOCup Lens Case with AODisc as part of the K013512, 20-Dec-2001; system) K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; K031521, 27-Jun-2003 D. Device Description: The two…
Ciba Vision Corporation2002—
*K023455Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…cting Solution (contains the AOCup Lens Case with AODisc as part of the K013512, 20-Dec-2001; system) K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; K031521, 27-Jun-2003 D. Device Description: The two color AOCup Lens Case wi…
Ciba Vision Corporation2003—
*K030522Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…the AOCup Lens Case with AODisc as part of the K013512, 20-Dec-2001; system) K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; K031521, 27-Jun-2003 D. Device Description: The two color AOCup Lens Case with AODisc is equivalent…
Ciba Vision Corporation2003—
*K031521Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…the AOCup Lens Case with AODisc as part of the K013512, 20-Dec-2001; system) K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; K031521, 27-Jun-2003 D. Device Description: The two color AOCup Lens Case with AODisc is equivalent to the predicate device…
Ciba Vision Corporation2003—

Also cleared against P820040: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.20171
K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc.20190

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 15 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K173538 (Alcon Laboratories, Inc., 2017) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate P820040.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LPN

2in 2022

2007: 42009: 12010: 22011: 32012: 22013: 22015: 22016: 32017: 12019: 22020: 32021: 22022: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007: 175 days median2011: 222 days median2016: 59 days median2020: 167 days median
2007high 222 (2011) · low 59 (2016)2026

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

Recalls per year · LPN

1in 2020

2007: 22009: 22010: 22011: 12016: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LPN

40in 2025

2007: 1,1512008: 1532009: 1212010: 2412011: 2732012: 2682013: 842014: 1052015: 1762016: 4982017: 2,6662018: 952019: 602020: 822021: 512022: 622023: 842024: 762025: 40
2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, 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
2007417521,151
20080—0153
20091—2121
20102—2241
201132221273
20122—0268
20132—084
20140—0105
20152—0176
20163591498
20171—02,666
20180—095
20192—060
20203167182
20212—051
20222—062
20230—084
20240—076
20250—040
20261—0—

What is it indicated for?

For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Indications for use as stated in the FDA summary.

Also cleared against P820040

3 other devices cite the same predicate.

  • K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019
  • K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017
  • K143351iCase Contact Lens CaseNovabay Pharmaceuticals, Inc. · 2015

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 LPN

The LPN category page

  • K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
  • K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated · 2022
  • K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
  • K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021
  • K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021

https://510kreport.com/device/K162597 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162597: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162597

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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