Skip to content

Durasoft 3 UV (Phemfilcon A) Optifit Toric Hydrophilic Contact Lenses

by Wesley Jessen Corp.

510(k) K982344

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982344 Date22 Dec 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis
510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Durasoft 3 UV (Phemfilcon A) Optifit Toric hydrophilic contact lenses are soft contact lenses made of phenfilcon A material, available in toric designs for the correction of refractive errors. These lenses are manufactured using lathe-cut technology and include UV-absorbing monomer variants for daily wear.

The lenses are supplied for daily wear and require daily cleaning, rinsing, and chemical disinfection by patients. They are authorized by FDA 510(k) clearance with product code LPL and device class 2, manufactured by Wesley Jessen Corp. for use under the supervision of eye care practitioners.

Other devices from Wesley Jessen Corp.

See all devices from Wesley Jessen Corp. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Durasoft 3 UV Optifit Toric contact lenses used for?

    These soft contact lenses are designed for the correction of refractive errors in patients with astigmatism, utilizing a toric design to provide proper vision correction. They are made of phenfilcon A material and include UV-absorbing properties for added eye protection.

  • How should Durasoft 3 UV Optifit Toric lenses be cared for?

    These lenses are supplied for daily wear and require daily cleaning, rinsing, and chemical disinfection by patients. Proper lens care is essential to maintain eye health and lens performance, following the instructions provided by eye care practitioners.

  • Are Durasoft 3 UV Optifit Toric lenses reusable or single-use?

    These are daily wear contact lenses that are not intended for extended wear or continuous use. They require removal and proper cleaning each day, and should not be worn while sleeping unless specifically directed by an eye care professional.

  • What is the regulatory status of Durasoft 3 UV Optifit Toric lenses?

    These lenses have received FDA 510(k) clearance with product code LPL and are classified as a class 2 medical device. They are manufactured by Wesley Jessen Corp. and intended for use under the supervision of qualified eye care practitioners.