# K123202: Proclear (Omafilcon a) Soft Hydrophilic) Contact Lens

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: May 30, 2013 after 230 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003136 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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 1.
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses, CooperVision, Inc. (2011) Summary page 1.

## Recalls of this device
- Sep 17, 2014 · Class III · Z-0134-2015: Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

## Indications for use
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.

Source page: https://510kreport.com/device/K123202
Methodology: https://510kreport.com/methodology