# K111966: Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XC

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Sep 15, 2011 after 66 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: 3 generations back to K003136 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952152: Proclear Daily Wear Contact Lens, Biocompatibles, Ltd. (1995) Summary page 3.
- K970095: Proclear Compatibles Daily Wear Contact Lens, Biocompatibles Eyewear, Inc. (1997) Summary page 3.
- K974408: Proclear (Omafilcon a) Daily Wear Contact Lens, Biocompatibles Eyewear, Inc. (1998) Summary page 3.
- K032873: Proclear Compatibles Multifocal, CooperVision, Inc. (2003) Summary page 3.
- K050717: Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal Toric, CooperVision, Inc. (2005) Summary page 3.
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens, CooperVision, Inc. (2006) Summary page 3.

## Indications for use
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: (omnafilcon 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 5.000 or less. Multifoical: (omnafilcon 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 2.000 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 and Proclear I Day (omrafilcon 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.

Source page: https://510kreport.com/device/K111966
Methodology: https://510kreport.com/methodology