510(k) Report

510(k) · Cleared

Cleared

D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses

K965052510(k) TraditionalCleared May 14, 1997147-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 May 14, 1997 after a 147-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
May 14, 1997
Review
147 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1998: 1 descendant cleared1995200020052010201520202025
  1. This deviceK965052 D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact LensesWesley Jessen Corp. · 1997
  2. Descendant · cites it directly · 0 of its ownK994335 Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp. · 2000
  3. Descendant · cites it directly · 0 of its ownK982344 Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac…Wesley Jessen Corp. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp. · 2000 · cites it directly0descendants
  • K982344Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV…Wesley Jessen Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K965052D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact LensesWesley Jessen Corp.1997—
+1K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp.2000—
+1K982344Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses…Wesley Jessen Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
FIG. 1 — Lineage of K965052, 1997–2000Source: 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? (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
*—D3 FreshLook LiteTint UV lenses
Named without a submission number
—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp.20000
K982344Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV…Wesley Jessen Corp.19980

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?

  • Of its descendants, K994335 (Wesley Jessen Corp., 2000) has gone furthest, with 0 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 DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction 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) Soft (hydrophilic) Contact Lenses…

Read the full statement (158 words)

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction 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) Soft (hydrophilic) Contact Lenses as 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 diopters (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.

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/K965052 · printed Nov 6, 2026

Cite this page

510(k) Report. “K965052: D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965052

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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