510(k) · Cleared

Recalled · Class II · 2022

Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde

K142284510(k) TraditionalCleared Jan 26, 2015161-day reviewClass II21 CFR 886.5928Recalls 1

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 Jan 26, 2015 as substantially equivalent to K003345 (Ciba Vision Corporation, 2001) and 7 other predicates after a 161-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it. It has been recalled once.

Decided: Jan 26, 2015
Review: 161 days
Class: Class II
Product code: LPN
Recalls: 1
Predicates: 8

Its longest line of descent runs back 2 generations to K003345 (2001). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK003345 Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
1 generation backK013512 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
This deviceK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015
Descendant · cites it directly · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
Descendant · 2 generations on · 0 of its ownK253795 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
Descendant · cites it directly · 0 of its ownK191795 AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019

Most influential descendants

Showing 3 of 3 · See all

K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · cites it directly1descendant
K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026 · 2 generations on0descendants
K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003345	Aosept Plus Cleaning and Disinfecting Solution	Ciba Vision Corporation	2001	—
−1	K013512	Aosept Clear Care Cleaning and Disinfecting Solution	Ciba Vision Corporation	2001	—
0 (this device)	K142284	Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde	Alcon Laboratories, Inc.	2015	—
+1	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	Menicon Co, Ltd.	2020	—
+2	K253795	MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	Menicon Co, Ltd.	2026	—
+1	K191795	AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K142284, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003345	Aosept Plus Cleaning and Disinfecting Solution Summary page 4 …modification of the predicate device, Clear Care® Cleaning & Disinfecting Solution, a legally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. I…	Ciba Vision Corporation	2001	—
*	K013512	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 4 …edicate device, Clear Care® Cleaning & Disinfecting Solution, a legally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other lega…	Ciba Vision Corporation	2001	—
*	K022687	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 4 …Care® Cleaning & Disinfecting Solution, a legally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other legally marketed devices t…	Ciba Vision Corporation	2002	—
*	K023455	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 4 …fecting Solution, a legally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other legally marketed devices to which substantial eq…	Ciba Vision Corporation	2003	—
*	K030522	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 4 …gally commercialized device in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other legally marketed devices to which substantial equivalence was demonstr…	Ciba Vision Corporation	2003	—
*	K031521	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 4 …e in the US per the following US FDA 510(k) clearances: K003345, 26-Mar-2001; K013512, 20-Dec-2001; K022687, 19-Nov-2002; K023455, 28-Feb-2003; K030522, 12-Sep-2003; and K031521, 27-Jun-2003. In addition, other legally marketed devices to which substantial equivalence was demonstrated include Bausch + Lomb…	Ciba Vision Corporation	2003	—
*	K020802	Renut Multiplus Mullti-Purpose Solution Summary page 5 …er legally marketed devices to which substantial equivalence was demonstrated include Bausch + Lomb renu® fresh™ multi-purpose solution [510(k) clearance K020802, 31-May-2002], and Boston Simplus® Multi-Action Solution [510(k) clearance K024289, 02-May-2003]. Device Description FID 120947A…	Bausch & Lomb, Incorporated	2002	2
*	K024289	Boston BL-1000-SIM08 Multi-Action Solution Summary page 5 …de Bausch + Lomb renu® fresh™ multi-purpose solution [510(k) clearance K020802, 31-May-2002], and Boston Simplus® Multi-Action Solution [510(k) clearance K024289, 02-May-2003]. Device Description FID 120947A is a sterile solution containing micro-filtered hydrogen peroxide 3% as the active…	Bausch & Lomb, Incorporated	2003	—

Also cleared against K003345: 5 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	Menicon Co, Ltd.	2020	1
K191795	AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2022	Class II	Z-1590-2022	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K191872 (Menicon Co, Ltd., 2020) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K003345.

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. 2015, this device’s year, is highlighted.

FDA decisions per year · LPN

2in 2022

2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007high 222 (2011) · low 59 (2016)2026

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

Recalls per year · LPN

1in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	175	2	1,151
2008	0	—	0	153
2009	1	—	2	121
2010	2	—	2	241
2011	3	222	1	273
2012	2	—	0	268
2013	2	—	0	84
2014	0	—	0	105
2015	2	—	0	176
2016	3	59	1	498
2017	1	—	0	2,666
2018	0	—	0	95
2019	2	—	0	60
2020	3	167	1	82
2021	2	—	0	51
2022	2	—	0	62
2023	0	—	0	84
2024	0	—	0	76
2025	0	—	0	40
2026	1	—	0	—

What is it indicated for?

CLEAR CARE PLUS Cleaning & Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142284: Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142284

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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