510(k) Report

510(k) · Cleared

Cleared

Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense)

K980818510(k) TraditionalCleared Mar 30, 199827-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stephen A. Dunn, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 30, 1998 as substantially equivalent to K953807 (Stephen A. Dunn, Inc., 1996) after a 27-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided
Mar 30, 1998
Review
27 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K953807 (1996). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2003: 1 descendant cleared2002: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK953807 · Daily Wear Soft (Hydrophilic) Contact Lens · Stephen A. Dunn, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K953807 · Daily Wear Soft (Hydrophilic) Contact Lens · Stephen A. Dunn, Inc. · 19960
  1. Root · 1 generation backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
  2. This deviceK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
  3. Descendant · cites it directly · 4 of its ownK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
  4. Descendant · cites it directly · 2 of its ownK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
  5. Descendant · 2 generations on · 1 of its ownK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
  6. Descendant · 3 generations on · 0 of its ownK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025
  7. Descendant · 2 generations on · 0 of its ownK142766 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12015: 12022: 12025: 1
2001high 1 (2001) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2001 · cites it directly4descendants
  • K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2002 · cites it directly2descendants
  • K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc. · 2022 · 2 generations on1descendant
  • K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025 · 3 generations on0descendants
  • K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953807Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc.1996—
0 (this device)K980818Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric…Stephen A. Dunn, Inc.1998—
+1K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted…Poly Vue Technolgies, Inc.2001—
+1K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.2002—
+2K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon)…INTEROJO, Inc.2022—
+3K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.2025—
+2K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
201510
202210
202510
FIG. 1 — Lineage of K980818, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K953807Daily Wear Soft (Hydrophilic) Contact Lens
Summary page 1
…o PolyVue Siiver Chord, Unisoft (methafilcon A) Spherical, Aspherical, and Toric Hydrophilic Contact Lenses for Daily Wear which received marketing clearance pursuant to K953807 as currently marketed in the U.S. The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal…
Stephen A. Dunn, Inc.1996—

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.20014
K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.20022
K030548Saview 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearSt. shine Optical Co., Ltd.20030

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?

  • Its one ancestor has no recall.
  • Of its descendants, K013220 (Poly Vue Technolgies, Inc., 2001) has gone furthest, with 4 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Muitifocal Hydrophilic Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in aphakic and not-aphakic persons with non-diseased eyes.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Stephen A. Dunn, Inc.

2 FDA decisions under this applicant name. See the company

  • K953807Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K980818 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980818: Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980818

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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