510(k) Report

510(k) · Cleared

Cleared

Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis

K982344510(k) TraditionalCleared Dec 22, 1998169-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

Wesley Jessen Corp. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 22, 1998 as substantially equivalent to K965052 (Wesley Jessen Corp., 1997) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1984.

Decided
Dec 22, 1998
Review
169 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to P830037 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorP830037 · Durasoft (R) 3 for Ext Wear · Alcon Laboratories, Inc. · 1984 · recalled19801985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor P830037 · Durasoft (R) 3 for Ext Wear · Alcon Laboratories, Inc. · 1984 · recalled0
  1. Root · 1 generation backP830037 Durasoft (R) 3 for Ext WearAlcon Laboratories, Inc. · 1984 · Recalled
  2. This deviceK982344 Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac…Wesley Jessen Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P830037Durasoft (R) 3 for Ext WearAlcon Laboratories, Inc.19842
0 (this device)K982344Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses…Wesley Jessen Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K982344, 1984–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K965052D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses
Summary page 2
…tact Lenses are substantially equivalent to previously marketed DuraSoft® 3UV lenses of the same material (phemfilcon A) as approved under 510(k) premarket notification, K965052 for daily wear and PMA 830037/S40 for extended wear. Carbazole violet has been listed as a color additive under 21 CFR 73.3107…
Wesley Jessen Corp.1997—
*P830037Durasoft (R) 3 for Ext Wear
Summary page 2
…let has been listed as a color additive under 21 CFR 73.3107 approved October 21, 1988 (53 FR 41322) as part of an approval of the sponsors opaque series of tints under P830037/S19 approved November 30, 1988. 0007 The opaque series of tints was approved as a surface entrapment tinting pro…
Alcon Laboratories, Inc.19842

Also cleared against K965052: 1 other device →

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?

  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K965052.

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 DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the cormrection of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters. The DuraSoft® 3 UV Spherical…

Read the full statement (168 words)

The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the cormrection of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.

The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

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

Also cleared against K965052

1 other device cites the same predicate.

  • K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp. · 2000

More from Wesley Jessen Corp.

138 FDA decisions under this applicant name. See the company

  • K000439Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical (…Wesley Jessen Corp. · 2000
  • K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp. · 2000
  • K993935Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a)…Wesley Jessen Corp. · 1999
  • K991000Gentle Touch UV (Netrafilcon a) Soft Contact LensesWesley Jessen Corp. · 1999
  • K991550Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (HYDROPHILIC0…Wesley Jessen Corp. · 1999

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/K982344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982344: Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982344

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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