# K032873: Proclear Compatibles Multifocal

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Nov 7, 2003 after 53 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: 1 generation back to K970095 (1997). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970095: Proclear Compatibles Daily Wear Contact Lens, Biocompatibles Eyewear, Inc. (1997) Summary page 1.
- K002625: Methafilcon a, CooperVision, Inc. (2000)

## Most influential descendants
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), 9 descendants of its own
- 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

## Indications for use
Proclear Compatibles 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 aphakic and/or 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. These 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. 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.

Source page: https://510kreport.com/device/K032873
Methodology: https://510kreport.com/methodology