510(k) Report

510(k) · Cleared

Cleared

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

K173538510(k) SpecialCleared Dec 4, 201719-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. · LRX Case, Contact Lens

Cleared on Dec 4, 2017 as substantially equivalent to K003345 (Ciba Vision Corporation, 2001) and 7 other predicates after a 19-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.

Decided
Dec 4, 2017
Review
19 days
Class
Class II
Product code
LRX
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K003345 (2001). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors2002: 1 other ancestor2019: 1 descendant clearedK003345 · Aosept Plus Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001K013512 · Aosept Clear Care Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001K162597 · Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc · Alcon Laboratories, Inc. · 2016200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K162597 · Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc · Alcon Laboratories, Inc. · 2016K013512 · Aosept Clear Care Cleaning and Disinfecting Solution · Ciba Vision Corporation · 2001K003345 · Aosept Plus Cleaning and Disinfecting Solution · Ciba Vision Corporation · 20010
  1. Root · 3 generations backK003345 Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
  2. 2 generations backK013512 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
  3. 1 generation backK162597 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2016
  4. This deviceK173538 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 1 of 1 · See all
  • K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003345Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation2001—
−2K013512Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation2001—
−1K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.2016—
0 (this device)K173538Clear 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
201910
FIG. 1 — Lineage of K173538, 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 LRX? 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 LRX device

  1. #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 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? (8)

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
*K003345Aosept Plus Cleaning and Disinfecting Solution
Summary page 5
…III. Predicate Device The legally marketed device(s) to which we are claiming substantial equivalence are: 510(k) Number Device K003345, 26-Mar- Clear Care Cleaning & Disinfecting Solution 2001; (contains the AOCup Lens Case…
Ciba Vision Corporation2001—
*K013512Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…sinfecting Solution 2001; (contains the AOCup Lens Case with AODisc as part of the system) K013512, 20-Dec- 2001; K022687, 19-Nov- 2002; K023455, 28-Feb- 2003;…
Ciba Vision Corporation2001—
*K022687Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…(contains the AOCup Lens Case with AODisc as part of the system) K013512, 20-Dec- 2001; K022687, 19-Nov- 2002; K023455, 28-Feb- 2003; K030522, 12-Sep- 2003;…
Ciba Vision Corporation2002—
*K023455Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…AODisc as part of the system) K013512, 20-Dec- 2001; K022687, 19-Nov- 2002; K023455, 28-Feb- 2003; K030522, 12-Sep- 2003; K031521, 27-Jun- 2003…
Ciba Vision Corporation2003—
*K030522Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…part of the system) K013512, 20-Dec- 2001; K022687, 19-Nov- 2002; K023455, 28-Feb- 2003; K030522, 12-Sep- 2003; K031521, 27-Jun- 2003 Previously AOCup Lens Case with…
Ciba Vision Corporation2003—
*K031521Aosept Clear Care Cleaning and Disinfecting Solution
Summary page 5
…c- 2001; K022687, 19-Nov- 2002; K023455, 28-Feb- 2003; K030522, 12-Sep- 2003; K031521, 27-Jun- 2003 Previously AOCup Lens Case with AODisc approved in PMA…
Ciba Vision Corporation2003—
*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
…ep- 2003; K031521, 27-Jun- 2003 Previously AOCup Lens Case with AODisc approved in PMA P820040, Supplement S032, 23-Oct-1995 (Reclassified to Class II in 1997) Special…
Ciba Vision Care—
*K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Summary page 5
…PMA P820040, Supplement S032, 23-Oct-1995 (Reclassified to Class II in 1997) Special 510k K162597, 19-Oct- 2016 IV. Device Description The AOCup Lens Case with AODisc is equivalent to the predicate devic…
Alcon Laboratories, Inc.2016—

Also cleared against K003345: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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 16 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K191795 (Alcon Laboratories, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K003345.

How does its category compare?

All LRX devices

LRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LRX

1in 2025

2007: 12009: 12010: 12011: 22012: 32013: 42014: 32015: 22016: 22017: 52023: 12024: 12025: 12026 (partial year): 1
2007high 5 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRX

49in 2017

2012: 103 days median2013: 72 days median2014: 249 days median2017: 49 days median
2007high 249 (2014) · low 49 (2017)2026

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

Recalls per year · LRX

No recall names LRX since 2007.

Adverse event reports per year · LRX

1in 2021

2012: 12014: 12017: 32021: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code LRX, 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
20071—00
20080—00
20091—00
20101—00
20112—00
2012310301
201347200
2014324901
20152—00
20162—00
201754903
20180—00
20190—00
20200—00
20210—01
20220—00
20231—00
20241—00
20251—00
20261—0—

What is it indicated for?

For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.

Indications for use as stated in the FDA summary.

Also cleared against K003345

5 other devices cite the same predicate.

  • K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019
  • K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2016
  • K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 20151 recall
  • K111877EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting SolutionBausch & Lomb, Inc. · 2012
  • K013512Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001

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 LRX

The LRX category page

  • K252175LANDR Contact LENS CaseFourth Axis, LLC · 2026
  • K250495Mini VP1 (PL67_F); Mini VP1 (PL61_F)Avizor S.A. · 2025
  • K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd. · 2024
  • K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023
  • K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017

https://510kreport.com/device/K173538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173538: 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 6, 2026. https://510kreport.com/device/K173538

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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