510(k) · Cleared
Recalled · Class II · 2013Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Nov 22, 2006 as substantially equivalent to K952152 (Biocompatibles, Ltd., 1995) and 5 other predicates after a 135-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- MVN
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 2 generations to K003136 (2001). 9 ancestors in all, the oldest K952152 (1995). 9 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 1 generation backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- This deviceK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
- Descendant · 2 generations on · 1 of its ownK180985 Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018
- Descendant · 3 generations on · 0 of its ownK253885 PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC)…Geo Medical CO., LTD. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc. · 2011 · cites it directly7descendants
- K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…CooperVision, Inc. · 2011 · cites it directly6descendants
- K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017 · cites it directly4descendants
- K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018 · 2 generations on1descendant
- K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…Geo Medical CO., LTD. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −1 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| 0 (this device) | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | — |
| +1 | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | CooperVision, Inc. | 2011 | — |
| +1 | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear… | CooperVision, Inc. | 2011 | — |
| +1 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017 | — |
| +2 | K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd | 2018 | — |
| +3 | K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS… | Geo Medical CO., LTD. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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 2…s is to be discarded after each removal. 6. Predicate Device(s) Predicate Device Materials omafilcon A: Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152) Proclear Compatibles Daily Wear Contact Lens (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compa… | 1995 |
| * | K970095 | Proclear Compatibles Daily Wear Contact LensSummary page 2…omafilcon A: Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152) Proclear Compatibles Daily Wear Contact Lens (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408) VAT Blue 6 (tint): Biomedics 52 1-Day… | 1997 |
| * | K974408 | Proclear (Omafilcon a) Daily Wear Contact LensSummary page 2…Proclear Compatibles Daily Wear Contact Lens (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408) VAT Blue 6 (tint): Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389… | 1998 |
| * | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensSummary page 2…bles (Omafilcon A) Soft Contact Lenses (K974408) VAT Blue 6 (tint): Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389) Predicate Device Lens Designs and Indications for Use Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K… | 2002 |
| * | K032873 | Proclear Compatibles MultifocalSummary page 2…ndications for Use Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K970095) Proclear Compatibles Multifocal (Omaflcon A) Soft Contact Lenses (K032873) Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft) Soft C… | 2003 |
| * | K050717 | Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal…Summary page 2…t Contact Lenses (K032873) Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft) Soft Contact Lenses (K050717) Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389) K061948 -5 10(k) S… | 2005 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | 2011 | 7 |
| K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &… | 2011 | 6 |
| K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | 2017 | 4 |
| K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear | 2022 | 0 |
| K111966 | Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XC | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2013 | Class II | Z-0542-2014 | Incorrect or no expiration date | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K110099 (CooperVision, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K952152.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 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: (omafilcon 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: (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. The lens may be worn by persons who have astigmatism of 5.OOD or less.
Multifocal: (omafilcon 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 2.00D 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 XC and Proclear 1day (omafilcqn 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 as stated in the FDA summary.
https://510kreport.com/device/K061948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061948
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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