510(k) · Cleared
ClearedProclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 15, 2011 as substantially equivalent to K952152 (Biocompatibles, Ltd., 1995) and 5 other predicates after a 66-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 15, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K003136 (2001). 10 ancestors in all, the oldest K952152 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 2 generations backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- 1 generation backK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- This deviceK111966 Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY…CooperVision, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −2 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| −1 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| 0 (this device) | K111966 | Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XC | CooperVision, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K952152 | Proclear Daily Wear Contact LensSummary page 3…510(k) Summary - CooperVision - Proclear and Proclear I Day 6. Predicate Device(s) Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K9521 52) Proclear Compatibles Daily Wear (Omaef/icon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (… | 1995 |
| * | K970095 | Proclear Compatibles Daily Wear Contact LensSummary page 3…Predicate Device(s) Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K9521 52) Proclear Compatibles Daily Wear (Omaef/icon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Oma fl/con A) Soft Contact Lenses (K974408) Proclear Compatibles Multifocal (… | 1997 |
| * | K974408 | Proclear (Omafilcon a) Daily Wear Contact LensSummary page 3…21 52) Proclear Compatibles Daily Wear (Omaef/icon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Oma fl/con A) Soft Contact Lenses (K974408) Proclear Compatibles Multifocal (0mafilcon A) Soft Contact Lenses (K032873) Proclear Multifocal (0mM//~con A), P… | 1998 |
| * | K032873 | Proclear Compatibles MultifocalSummary page 3…970095) Proclear and Proclear Compatibles (Oma fl/con A) Soft Contact Lenses (K974408) Proclear Compatibles Multifocal (0mafilcon A) Soft Contact Lenses (K032873) Proclear Multifocal (0mM//~con A), Proclear Toric (Ona ffIcon A) and Proclear Multifocal Toric (Ona ffIcon A) So… | 2003 |
| * | K050717 | Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal…Summary page 3…ntact Lenses (K032873) Proclear Multifocal (0mM//~con A), Proclear Toric (Ona ffIcon A) and Proclear Multifocal Toric (Ona ffIcon A) Soft Contact Lenses (K050717) Proclear XC and Proclear 1 Day (Omaefl/con A) Soft Contact Lenses (K061948) 7. Characteristics of Substantial Equ… | 2005 |
| * | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensSummary page 3…a ffIcon A) and Proclear Multifocal Toric (Ona ffIcon A) Soft Contact Lenses (K050717) Proclear XC and Proclear 1 Day (Omaefl/con A) Soft Contact Lenses (K061948) 7. Characteristics of Substantial Equivalence The soft contact lenses have the following similarities to the pre… | 2006 |
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 10 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K952152.
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. 2011, 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?
Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. Toric: (omnafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased…
Read the full statement (314 words)
Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Toric: (omnafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.000 or less.
Multifoical: (omnafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.000 or less that does not interfere with visual acuity.
Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.
Proclear and Proclear I Day (omrafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111966: Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111966
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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