# K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Nov 22, 2006 after 135 days
- Product code: MVN (Lens, Contact, (Disposable))
- 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: 2 generations back to K003136 (2001). 9 ancestors in all.
9 later devices descend from it; 5 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)
- K952152: Proclear Daily Wear Contact Lens, Biocompatibles, Ltd. (1995) Summary page 2.
- K970095: Proclear Compatibles Daily Wear Contact Lens, Biocompatibles Eyewear, Inc. (1997) Summary page 2.
- K974408: Proclear (Omafilcon a) Daily Wear Contact Lens, Biocompatibles Eyewear, Inc. (1998) Summary page 2.
- K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens, Ocular Sciences (2002) Summary page 2.
- K032873: Proclear Compatibles Multifocal, CooperVision, Inc. (2003) Summary page 2.
- K050717: Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal Toric, CooperVision, Inc. (2005) Summary page 2.

## Most influential descendants
- K110099: Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft (Hydrophilic) Contact Lens; Proclear Mult (2011), 7 descendants of its own
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses (2011), 6 descendants of its own
- 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

## Recalls of this device
- Nov 20, 2013 · Class II · Z-0542-2014: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

## 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: (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. The lens may be worn by persons who have astigmatism of 5.OOD or less. Multifocal: (omafilcon 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 2.00D 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 XC and Proclear 1day (omafilcqn 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/K061948
Methodology: https://510kreport.com/methodology