510(k) · Cleared
ClearedEZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LPN Accessories, Soft Lens Products
Cleared on Jan 24, 2012 as substantially equivalent to K003345 (Ciba Vision Corporation, 2001) and 2 other predicates after a 207-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 24, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003345 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK111877 EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05…Bausch & Lomb, Inc. · 2012
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) | K111877 | EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and… | Bausch & Lomb, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K003345 | Aosept Plus Cleaning and Disinfecting SolutionSummary page 1…lens care products Device classification: Class 11 (21 CFR §886.5928) Product Code: LPN 3. Predicate Devices Ciba AOSEPT Disinfecting Solution (K003345, K01 3512) Ciba Clear Care Cleaning and Disinfecting Solution (K022687) 4. Description of the Device BAUSCH + LOMB EZS05… | 2001 |
| * | K013512 | Aosept Clear Care Cleaning and Disinfecting SolutionSummary page 1…products Device classification: Class 11 (21 CFR §886.5928) Product Code: LPN 3. Predicate Devices Ciba AOSEPT Disinfecting Solution (K003345, K01 3512) Ciba Clear Care Cleaning and Disinfecting Solution (K022687) 4. Description of the Device BAUSCH + LOMB EZS05 Disinfecti… | 2001 |
| * | K022687 | Aosept Clear Care Cleaning and Disinfecting SolutionSummary page 1…) Product Code: LPN 3. Predicate Devices Ciba AOSEPT Disinfecting Solution (K003345, K01 3512) Ciba Clear Care Cleaning and Disinfecting Solution (K022687) 4. Description of the Device BAUSCH + LOMB EZS05 Disinfecting Solution is a sterile, buffered 3% hydrogen peroxide solut… | 2002 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K003345.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
BAUSCH + LOMB EZSO5 Disinfecting Solution is indicated for disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111877: EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111877
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