510(k) · Cleared
Recalled · 2007Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 12, 2004 as substantially equivalent to K020139 (Ciba Vision Corporation, 2002) after an 85-day review. Its family tree reaches back 3 generations to 1981. 94 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810005 (1981). 5 ancestors in all. 94 later devices descend from it, 10 citing it directly.
- Root · 3 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 2 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 1 generation backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- This deviceK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004
- Descendant · cites it directly · 74 of its ownK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- Descendant · cites it directly · 14 of its ownK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 12 of its ownK141348 Visco Soft Contact LensVisco Vision, Inc. · 2015
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · cites it directly74descendants
- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 2 generations on32descendants
- K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008 · cites it directly17descendants
- K071736Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · cites it directly14descendants
- K141348Visco Soft Contact LensVisco Vision, Inc. · 2015 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −2 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −1 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| 0 (this device) | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | — |
| +1 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| +2 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +1 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| +1 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| +2 | K141348 | Visco Soft Contact Lens | Visco Vision, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 9 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 12 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignSummary page 1…ow water, nonionic polymer). CIBA Vision obtained FDA 510(k) clearance for ExcelensTM (lotrafilcon B) lenses for daily wear on April 9, 2002 (K020139). 4. Description of Device: The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydr… | 2002 |
What descends from it? (94)
See all 9410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052560 | Biofinity (Comfilcon a) Soft Contact Lens | 2005 | 74 |
| K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | 2008 | 17 |
| K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | 2008 | 14 |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens… | 2013 | 6 |
| K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker | 2013 | 2 |
| K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens | 2009 | 1 |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus… | 2016 | 0 |
| K133740 | Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal… | 2014 | 0 |
| K133472 | Sauflon Clariti 1 Day with Tint (Toric/Multifocal) | 2014 | 0 |
| K062262 | Ciba Vision (Sifilcon a) Spherical, Toric, Multifocal and Multifocal Toric Designs | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2007 | Not classified | Z-0427-2007 | Other | Reduced Ion Permeability |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K052560 (CooperVision, Inc., 2005) has gone furthest, with 74 descendants of its own.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or…
Read the full statement (214 words)
The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.
The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033919
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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