510(k) · Cleared
ClearedEzview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-See Vision Technology, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 16, 2009 as substantially equivalent to K020927 (Bausch & Lomb, 2002) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 16, 2009
- Review
- 260 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960926 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 1 generation backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- This deviceK082883 Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily WearI-See Vision Technology, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK151847 SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −1 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| 0 (this device) | K082883 | Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear | I-See Vision Technology, Inc. | 2009 | — |
| +1 | K151847 | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | Smart Performer Corp., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensSummary page 1…Predicate Device: * BAUSH &LOMB® SofLens MultiFocal (Polymacon) Visibility Tinted T M Contact Lens cleared via K020927 BAUSCH & LOMB®. * SuperView (polymacon) Contact Lens for Daily Wear (K033136) made from INNOVA VISION INC. 0 Opt… | 2002 |
| * | K033136 | I-Lux Innova Blue Tint Lens, Model Super O2Summary page 1…Visibility Tinted T M Contact Lens cleared via K020927 BAUSCH & LOMB®. * SuperView (polymacon) Contact Lens for Daily Wear (K033136) made from INNOVA VISION INC. 0 Optima FWTM (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S0… | 2004 |
| * | — | Optima FW (polymacon) Visibility Tinted Contact Lenses Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151847 | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | 2016 | 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 13 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151847 (Smart Performer Corp., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K020927.
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. 2009, 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?
EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity..
Eyecare practitioners may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082883: Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082883
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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