510(k) Report

510(k) · Cleared

Cleared

Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone Toric Aspherical (Methafilcon a)S

K011577510(k) TraditionalCleared Jun 19, 200128-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

Ocu-Ease Optical Products, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jun 19, 2001 as substantially equivalent to K992010 (Westcon Contact Lens Co., Inc., 1999) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jun 19, 2001
Review
28 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K954524 (1996). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 1 other ancestorK954524 · W-55 (Methafilon a) Contact Lens · Westcon Contact Lens Co., Inc. · 1996K992010 · W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted) · Westcon Contact Lens Co., Inc. · 19991996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors K992010 · W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted) · Westcon Contact Lens Co., Inc. · 1999K954524 · W-55 (Methafilon a) Contact Lens · Westcon Contact Lens Co., Inc. · 19960
  1. Root · 2 generations backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
  2. 1 generation backK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
  3. This deviceK011577 Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric…Ocu-Ease Optical Products, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954524W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc.1996—
−1K992010W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55…Westcon Contact Lens Co., Inc.1999—
0 (this device)K011577Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and…Ocu-Ease Optical Products, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
FIG. 1 — Lineage of K011577, 1996–2001Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K992010W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear)…
Summary page 2
…te device(s) identified below in terms of intended use and design. Predicate Device: Horizon 55 (methafilcon A) Sphere, Toric, Progressive, Progressive Toric 510(k) #K992010 Manufactured By: Westcon Contact Lens Device Description: The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric…
Westcon Contact Lens Co., Inc.1999—
*K980418Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft…
Summary page 4
…ducts, Inc. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ — MF (methafilcon A), 510k #K980418 and K003861. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to…
Benz Research and Development Corp.1998—
*K003861Benz-MF (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens…
Summary page 4
…The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ — MF (methafilcon A), 510k #K980418 and K003861. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicat…
Benz Research and Development Corp.2001—

Also cleared against K992010: 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?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K992010.

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 Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic…

Read the full statement (269 words)

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correct of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The lens may be disinfected with a chemical (not heat) 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 K992010

1 other device cites the same predicate.

  • K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004

More from Ocu-Ease Optical Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K023077Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear (Lathe-Cut)Ocu-Ease Optical Products, Inc. · 2002
  • K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002
  • K003996Ocu-Flex-53 Thin Zone Toric and Thin Zone Toric Aspherical (Ocufilcon) Soft Contact Lenses for Daily WearOcu-Ease Optical Products, Inc. · 2001
  • K004000Ocu-Flex-49 Thin Zone Toric and Thin Z0NE Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily…Ocu-Ease Optical Products, Inc. · 2001
  • K002966Ocu-Flex-49 Spherical, Toric, Aspherical and Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily…Ocu-Ease Optical Products, Inc. · 2000

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/K011577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011577: Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone Toric Aspherical (Methafilcon a)S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011577

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026