# K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Dec 21, 2011 after 132 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003136 (2001). 12 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110099: Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft (Hydrophilic) Contact Lens; Proclear Mult, CooperVision, Inc. (2011) Summary page 3.
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens, CooperVision, Inc. (2006) Summary page 3.

## Most influential descendants
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (2017), 4 descendants of its own
- K180985: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (2018), 1 descendant of its own
- K253885: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES (2026), 0 descendants of its own
- K213983: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (2022), 0 descendants of its own
- K201013: Optixon 1-Day (2020), 0 descendants of its own

## Indications for use
Proclear Multifotcal 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 nondiseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic. Proclear Multifocal XR (omnafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased 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 Tonec XR (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 which possess astigmatism corrections to -5.75 diopters. Proclear Sphere and Asphere: (omafilcon A) 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 2.0013 or less that does not interfere with visual acuity. Proclear Torie: (omafilcon A) 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 The lens may be worn by persons who have astigmatism of 5.000 or less. Proclear Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive arnetropia (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 (oinafilcon 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 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

Source page: https://510kreport.com/device/K112302
Methodology: https://510kreport.com/methodology