510(k) · Cleared
Recalled · Class II · 2022Opti-Free Express Multi-Purpose Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Universal, Ltd. · LPN Accessories, Soft Lens Products
Cleared on Aug 8, 2002 as substantially equivalent to K973332 (Alcon Laboratories, 1997) and 4 other predicates after a 121-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Aug 8, 2002
- Review
- 121 days
- Class
- Class II
- Product code
- LPN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K974624 (1998). 7 ancestors in all, the oldest K973332 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK974624 Alcon Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1998
- This deviceK021143 Opti-Free Express Multi-Purpose Disinfecting SolutionAlcon Universal, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974624 | Alcon Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1998 | — |
| 0 (this device) | K021143 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
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
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K973332 | Alcon Multi-Purpose Disinfecting Solution ID 90746Summary page 2…substantially equivalent, in terms of its actions and indications for use, to OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution, cleared for marketing under 5 1O(k) K973332 (originally submitted as P830034/S32), K974624, K983780, KO01214 (no rub directions for use for lenses replaced within 30 days or… | 1997 |
| * | K974624 | Alcon Multi-Purpose Disinfecting Solution ID 90746Summary page 2…ons and indications for use, to OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution, cleared for marketing under 5 1O(k) K973332 (originally submitted as P830034/S32), K974624, K983780, KO01214 (no rub directions for use for lenses replaced within 30 days or less) and KO02589 (no rub directions for all l… | 1998 |
| * | K983780 | Multi-Purpose Disinfecting Solution ID 90746Summary page 2…ndications for use, to OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution, cleared for marketing under 5 1O(k) K973332 (originally submitted as P830034/S32), K974624, K983780, KO01214 (no rub directions for use for lenses replaced within 30 days or less) and KO02589 (no rub directions for all lenses). O… | 1998 |
| * | K001214 | Opti-Free Express Multi-Purpose Disinfecting Solution | 2000 |
| * | K002589 | Opti-Free Express Multi-Purpose Disinfecting Solution | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2022 | Class II | Z-1540-2022 | Storage | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K973332.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 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 (including silicone hydrogel lenses) as recommended by your eye care practitioner.
OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE SUPRACLENS Daily Protein Remover.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021143: Opti-Free Express Multi-Purpose Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021143
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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