510(k) · Cleared
Recalled · Class III · 2014Proclear (Omafilcon a) Soft Hydrophilic) Contact Lens
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 May 30, 2013 as substantially equivalent to K110099 (CooperVision, Inc., 2011) and 1 other predicate after a 230-day review. Its family tree reaches back 5 generations to 2001. It has been recalled once.
- Decided
- May 30, 2013
- Review
- 230 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003136 (2001). 13 ancestors in all, the oldest K952152 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 4 generations backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- 3 generations backK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- 2 generations backK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- 1 generation backK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- This deviceK123202 Proclear (Omafilcon a) Soft Hydrophilic) Contact LensCooperVision, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −4 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| −3 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| −2 | 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 | — |
| 0 (this device) | K123202 | Proclear (Omafilcon a) Soft Hydrophilic) Contact Lens | CooperVision, Inc. | 2013 | — |
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 |
| 2008 | 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 |
|---|---|---|---|
| * | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…Summary page 1…ocal XR, Proclear Multifocal Toric, Proclear Sphere and Asphere, Proclear Toric, Proclear Multifocal (K110099, K112302) Device Description: The Proclear lens is composed of polymer of 2-hydroxy-ethytmethacrylate and 2-metacryloloyoxyethy… | 2011 |
| * | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…Summary page 1…Proclear Multifocal Toric, Proclear Sphere and Asphere, Proclear Toric, Proclear Multifocal (K110099, K112302) Device Description: The Proclear lens is composed of polymer of 2-hydroxy-ethytmethacrylate and 2-metacryloloyoxyethyl phospho… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2014 | Class III | Z-0134-2015 | Other | Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K110099.
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. 2013, 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?
Proclear Multifocal Taric (omafilcon B) 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 which, possess astigmatism to -5.75 diopters or less, and are presbyopic. Proclear Multifocal XR .(omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and…
Read the full statement (390 words)
Proclear Multifocal Taric (omafilcon B) 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 which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR .(omafilcon B) 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.
Proclear Toric XR (omnafilcon B) 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 hyperopi6 which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non- diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.000 or less that does not interfere with visual acuity.
Proclear Toric: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for-the-correction-of-visual-acuity-in-ron-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.
Proclear Multifocal: (omnafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in non-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.
Proclear (omafilcon B) 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 eye care practitioners in consultation with their patients.
FREQUENT PLANNED REPLACEMENT WEAR
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses 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/K123202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123202: Proclear (Omafilcon 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/K123202
Report an extraction error
Are you the manufacturer?
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