510(k) · Cleared

Cleared

Soft (Hydrophilic) Contact Lens Care Solution

K031193510(k) TraditionalCleared Jul 3, 200378-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, Inc. · LPN Accessories, Soft Lens Products

Cleared on Jul 3, 2003 as substantially equivalent to P830034/S026 (Alcon Laboratories, 1995) after a 78-day review. Its family tree reaches back 1 generation to 1995.

Decided: Jul 3, 2003
Review: 78 days
Class: Class II
Product code: LPN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P830034/S026 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backP830034/S026 Opti-Free Rinsing,Disinfecting & Storage SolutionAlcon Laboratories · 1995
This deviceK031193 Soft (Hydrophilic) Contact Lens Care SolutionAlcon, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P830034/S026	Opti-Free Rinsing,Disinfecting & Storage Solution	Alcon Laboratories	1995	—
0 (this device)	K031193	Soft (Hydrophilic) Contact Lens Care Solution	Alcon, Inc.	2003	—

FIG. 1 — Lineage of K031193, 1995–2003Source: 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	P830034/S026	Opti-Free Rinsing,Disinfecting & Storage Solution A supplement to the PMA, as the summary prints it.	Alcon Laboratories	1995	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

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.

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?

For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

OPTI-ONE Multi-Purpose Solution (modified directions for use) can also be used as a diluent for OPTI-ZYME Enzymatic Cleaner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031193 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031193: Soft (Hydrophilic) Contact Lens Care Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031193

Report an extraction error

Are you the manufacturer?

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