# K982344: Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Dec 22, 1998 after 169 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 P830037 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965052: D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses, Wesley Jessen Corp. (1997) Summary page 2.
- P830037: Durasoft (R) 3 for Ext Wear, Alcon Laboratories, Inc. (1984) Summary page 2.

## Indications for use
The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the cormrection of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters. The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters. The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K982344
Methodology: https://510kreport.com/methodology