# K043129: Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a) Soft (Hydrophilic Contact Lens)

- Pathway: 510(k) (Traditional)
- Applicant: Opti-Centre Laboratories
- Decided: Jan 12, 2005 after 61 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Proclear Toric: named in the summary without a submission number
- (no number) Proclear Multifocal: named in the summary without a submission number

## Most influential descendants
- K050717: Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal Toric (2005), 10 descendants of its own
- 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

## Indications for use
Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal 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 non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The 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). Proclear UltraVue/D and Proclear UltraVue/N Multifocal (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 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. The 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 the eye care practitioner 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 lenses may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K043129
Methodology: https://510kreport.com/methodology