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Vistakon Lenefilcon A Soft Hydrophilic Contact Lens

by Johnson & Johnson Vision Care, Inc.

PMA P990085510(k) K994318

Active United States

PMA, withdrawn 510(k)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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP990085 Date16 Feb 2001ApprovedStatusWithdrawn
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK994318 Date23 Feb 2000ClearedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker
Generic Name
Lenses, soft contact, extended wear
FDA applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
PMA Number
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, 18 Sep 2026

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

The Vistakon Lenefilcon A soft hydrophilic contact lens is a vision correction device designed for both daily and extended wear. It is indicated for the correction of refractive ametropia, including myopia and hyperopia, in non-aphakic persons with non-diseased eyes, as well as for daily wear in aphakic individuals.

These lenses are available in spherical, bifocal, toric, and toric bifocal configurations to address specific vision needs, including presbyopia and astigmatism up to 10.00 diopters. The lenses are manufactured by Johnson & Johnson Vision Care, Inc. and are provided in both clear and visibility-tinted options with an integrated UV blocker.

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Questions

AI-generated answers, 18 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 conditions can the Vistakon Lenefilcon A lens correct?

    The lens is indicated for the correction of refractive ametropia, specifically myopia and hyperopia, in non-aphakic persons. It is also suitable for distance and near vision correction in presbyopic individuals and can accommodate varying degrees of astigmatism depending on the specific lens model.

  • Is this lens suitable for aphakic patients?

    Yes, the Vistakon Lenefilcon A contact lens is indicated for daily wear in aphakic persons, provided they have non-diseased eyes.

  • Does this contact lens provide protection from UV light?

    Yes, the Vistakon Lenefilcon A soft hydrophilic contact lens is manufactured with an integrated UV blocker to assist in protecting the eye from ultraviolet radiation.