510(k) · Cleared
Recalled · Class II · 2017Vistakon (Galyfilcon a) Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Vision Care, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 16, 2003 after a 79-day review. The FDA summary names its predicate without a number. 33 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 0
33 later devices descend from it, 2 citing it directly.
- This deviceK032340 Vistakon (Galyfilcon a) Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2003
- Descendant · cites it directly · 30 of its ownK073485 Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008
- Descendant · 2 generations on · 13 of its ownK100349 Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010
- Descendant · 3 generations on · 12 of its ownK113168 Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal…Ciba Vision Corporation · 2012
- Descendant · 2 generations on · 8 of its ownK160344 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens…Visco Vision, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K073485Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008 · cites it directly30descendants
- K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010 · 2 generations on13descendants
- K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…Ciba Vision Corporation · 2012 · 3 generations on12descendants
- K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc. · 2016 · 2 generations on8descendants
- K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd. · 2013 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032340 | Vistakon (Galyfilcon a) Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2003 | — |
| +1 | K073485 | Vistakon (Narafilcon) a Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2008 | — |
| +2 | K100349 | Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. | 2010 | — |
| +3 | K113168 | Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies… | Ciba Vision Corporation | 2012 | — |
| +2 | K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy… | Visco Vision, Inc. | 2016 | — |
| +2 | K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable… | Sauflon Pharmaceuticals, Ltd. | 2013 | 17 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | — | Focus NIGHT AND DAY (lotrafilcon A) Named without a submission number |
What descends from it? (33)
See all 332 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 |
|---|---|---|---|---|
| Oct 19, 2017 | Class II | Z-1210-2018 | Packaging process control | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073485 (Johnson & Johnson Vision Care, Inc., 2008) has gone furthest, with 30 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 VISTAKON®(galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.OOD or less of astigmatism. The VISTAKON®(galyfilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of…
Read the full statement (211 words)
The VISTAKON®(galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.OOD or less of astigmatism.
The VISTAKON®(galyfilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON®(galyfilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON* (galyfilcon A) Toric-Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON®(galyfilcon A) UV Blocking Contact Lenses help protect against transmission of harmful W radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequenuplanned replacement wear with cleaning, disinfection and scheduled replacement (see “Wearing Schedule”). When prescribed for frequenuplanned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032340: Vistakon (Galyfilcon a) Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032340
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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