510(k) · Cleared
ClearedProclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a) Soft (Hydrophilic Contact Lens)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opti-Centre Laboratories · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jan 12, 2005 after a 61-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Jan 12, 2005
- Review
- 61 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK043129 Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal…Opti-Centre Laboratories · 2005
- Descendant · cites it directly · 10 of its ownK050717 Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear…CooperVision, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 7 of its ownK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- Descendant · 3 generations on · 6 of its ownK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K050717Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal…CooperVision, Inc. · 2005 · cites it directly10descendants
- K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · 2 generations on9descendants
- K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc. · 2011 · 3 generations on7descendants
- K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…CooperVision, Inc. · 2011 · 3 generations on6descendants
- K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043129 | Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric… | Opti-Centre Laboratories | 2005 | — |
| +1 | K050717 | Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T… | CooperVision, Inc. | 2005 | — |
| +2 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| +3 | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | CooperVision, Inc. | 2011 | — |
| +3 | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear… | CooperVision, Inc. | 2011 | — |
| +3 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Proclear Toric Named without a submission number | |
| * | — | Proclear Multifocal Named without a submission number |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050717 (CooperVision, Inc., 2005) has gone furthest, with 10 descendants of its own.
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.
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?
Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A)Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to…
Read the full statement (241 words)
Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A)Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The 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).
Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A)Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The 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 the eye care practitioner in consultation with their patients. 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 lenses may be disinfected using a chemical disinfection system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043129: Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a) Soft (Hydrophilic Contact Lens).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043129
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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