510(k) · Cleared
Recalled · Class II · 2014BPZ02 Multipurpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Nov 18, 2009 as substantially equivalent to K033608 (Ciba Vision Corporation, 2004) and 1 other predicate after a 336-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 18, 2009
- Review
- 336 days
- Class
- Class II
- Product code
- LYL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021635 (2002). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021635 Karats Multipurpose SolutionCiba Vision Corporation · 2002
- 1 generation backK033608 Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004
- This deviceK083757 BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK210051 OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021
- Descendant · cites it directly · 0 of its ownK102860 Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| −1 | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| 0 (this device) | K083757 | BPZ02 Multipurpose Solution | Bausch & Lomb, Inc. | 2009 | — |
| +1 | K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021 | — |
| +1 | K102860 | Alcon Multi-Pirpose Disinfecting Solution | Alcon Research, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 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 LYL? 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 LYL device
- #1 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K033608 | Aquify Multi-Purpose SolutionSummary page 1…or Lenses Device classification: Class 11 (21 CFR §886.5928) Product Code: LYL 3. Predicate Devices CIBA Vision AQuify Multi-Purpose Solution (K033608) Alcon OPTI-FREESg RepleniSH® Multi-Purpose Disinfecting Solution (K050729) 4. Description of the Device Bausch & Lomb B… | 2004 |
| * | K050729 | Alcon Multi-Purpose Disinfecting SolutionSummary page 1…Code: LYL 3. Predicate Devices CIBA Vision AQuify Multi-Purpose Solution (K033608) Alcon OPTI-FREESg RepleniSH® Multi-Purpose Disinfecting Solution (K050729) 4. Description of the Device Bausch & Lomb BPZ02 MultiPurpose Solution is a sterile, isotonic solution that contains hy… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2014 | Class II | Z-0126-2015 | Other | Product lot did not meet the specification for its disinfectants at the time of manufacture. |
| Apr 21, 2014 | Class II | Z-1554-2014 | Nonconforming Material/Component | Out of specification results for one of the two disinfectants. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210051 (Ote North America, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033608.
How does its category compare?
All LYL devicesLYL Accessories, Solution, Ultrasonic Cleaners For Lenses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LYL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LYL
Too few LYL 510(k)s in any year since 2007 to give a median.
Recalls per year · LYL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYL
4in 2025
MAUDE reports naming product code LYL, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 8 | 9 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 1 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083757: BPZ02 Multipurpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083757
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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