510(k) · Cleared
ClearedCiba Vision (Lotrafilcon B) Soft Contact Lenses
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 Feb 28, 2008 as substantially equivalent to K033919 (Ciba Vision Corporation, 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 4 generations to 1981. 17 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P810005 (1981). 6 ancestors in all. 17 later devices descend from it, 9 citing it directly.
- Root · 4 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 3 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 2 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 1 generation backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- This deviceK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- Descendant · cites it directly · 6 of its ownK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK181920 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable…CooperVision, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK133176 Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
- Descendant · cites it directly · 2 of its ownK130342 Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with…Sauflon Pharmaceuticals, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK242413 VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic)…Vizionfocus, Inc. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd. · 2013 · cites it directly6descendants
- K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…CooperVision, Inc. · 2018 · 2 generations on3descendants
- K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014 · cites it directly2descendants
- K130342Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSauflon Pharmaceuticals, Ltd. · 2013 · cites it directly2descendants
- K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Vizionfocus, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −3 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −2 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −1 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| 0 (this device) | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| +1 | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable… | Sauflon Pharmaceuticals, Ltd. | 2013 | 17 |
| +2 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens… | CooperVision, Inc. | 2018 | 1 |
| +1 | K133176 | Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal | Ciba Vision Corporation | 2014 | — |
| +1 | K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
| +3 | K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily… | Vizionfocus, Inc. | 2024 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 1…ic polymer). CIBA VISION obtained FDA Premarket Notification 510(k) Clearance for plasma treated (lotrafilcon B) lenses for daily wear on March 12, 2004 (K033919). 4. Description of Device: The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing… | 2004 |
| * | K970746 | SEE3 (Lotrafilcon a) Soft Contact LensSummary page 4…lymer). CIBA VISION obtained FDA Premarket Notification 510(k) Clearance for plasma treated (lotrafilcon A) lenses for daily wear on May 9, 1997 (K970746). 4. Description of Device: The lens material is 24% water and 76% lotrafilcon A, a fluoro-silicone containing… | 1997 |
What descends from it? (17)
See all 179 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens… | 2013 | 6 |
| K133176 | Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal | 2014 | 2 |
| K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker | 2013 | 2 |
| K141670 | Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia | 2014 | 1 |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | 2018 | 0 |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus… | 2016 | 0 |
| K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL… | 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 |
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 27 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K130331 (Sauflon Pharmaceuticals, Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K033919.
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. 2008, this device’s year, is highlighted.
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?
CIBA VISION® (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. CIBA VISION® Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic…
Read the full statement (490 words)
CIBA VISION® (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
CIBA VISION® Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D)or less of astigmatism.
CIBA VISION® Multifocal (lotrafilcon B) soft contact lenses are 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.
CIBA VISION® Multifocal Toric (lotrafilcon B) soft contact lenses are 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 6.00 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.
CIBA VISION® spherical (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
CIBA VISION® toric (lotrafilcon A) soft contact lenses are 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.
CIBA VISION® multifocal (lotrafilcon A) soft contact lenses are 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.
CIBA VISION® multifocal toric (lotrafilcon A) soft contact lenses are 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.
In addition, CIBA VISION® (lotrafilcon A) lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073459
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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