510(k) · Cleared
ClearedEye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yung Sheng Optical Co., Ltd. · MVN Lens, Contact, (Disposable)
Cleared on Jan 16, 2015 as substantially equivalent to K132854 (Yung Sheng Optical Co., Ltd., 2013) after a 72-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jan 16, 2015
- Review
- 72 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960926 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 2 generations backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- 1 generation backK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
- This deviceK143190 Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −2 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| −1 | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2013 | — |
| 0 (this device) | K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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 |
|---|---|---|---|
| * | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 4…ct Lens for Daily Wear Manufacturer: Yung Sheng Optical Co., Ltd. 510(k) Number or Clearance Information: K132854 5.1 Yung Sheng Optical C… | 2013 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K132854.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professional should prescribe the lenses for daily wear single use only. The lenses…
Read the full statement (113 words)
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear
single use only for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with
non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that
does not interfere with visual acuity. The eye care professional should prescribe the lenses for daily wear single
use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against
transmission of harmful UV radiation to the cornea and into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143190: Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143190
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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