# K982110: Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Optech, Inc.
- Decided: Nov 6, 1998 after 143 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 K963764 (1997). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963764: Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear, Specialty Ultravision, Inc. (1997) Summary page 1.

## Most influential descendants
- K013220: HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2001), 4 descendants of its own
- K020608: HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2002), 2 descendants of its own
- K221517: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (2022), 1 descendant of its own
- K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (2025), 0 descendants of its own
- K142766: I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (2015), 0 descendants of its own

## Indications for use
The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in aphakic and non-aphakic persons with non-diseased eyes. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K982110
Methodology: https://510kreport.com/methodology