VISTAKON (Senofilcon A) Contact Lenses
by Vistakon, Division of Johnson & Johnson Vision Car
PMA P040045
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP040045 | Date20 Dec 2005 | StatusActive |
Recalls
-
- Terminated Z-1209-2018
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- VISTAKON (senofilcon A) Brand Contact Lenses
- Trade Name
- Vistakon (Senofilcon a) Contact Lens, Clear and Visibility Tinted with UV Blocker
- Generic Name
- Lenses, soft contact, extended wear
- PMA Number
- FDA Product Code
- LPM
- Device Class
- Class III
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Vistakon (senofilcon A) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.00D or less of astigmatism. The device is available in spherical, multifocal, toric, and multifocal-toric designs for various vision correction needs and includes UV blocking properties to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses may be prescribed for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement using a chemical disinfection system only. They can be worn for daily wear and extended wear for up to 6 nights/7 days of continuous wear, with recommended evaluation on a daily wear schedule first. The device is classified as a Class III medical device with FDA PMA approval.
Questions
AI-generated answers, 18 Sep 2026
What vision conditions can the Vistakon (senofilcon A) contact lens correct?
The Vistakon contact lens is designed to correct refractive ametropia including myopia and hyperopia in phakic or aphakic persons with non-diseased eyes who have 1.00D or less of astigmatism. It's available in spherical, multifocal, toric, and multifocal-toric designs for various vision correction needs.
How should the Vistakon contact lenses be worn and cared for?
These lenses may be prescribed for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement using a chemical disinfection system only. They can be worn for daily wear and extended wear for up to 6 nights/7 days of continuous wear, though daily wear evaluation is recommended first.
What special features do the Vistakon contact lenses offer?
The Vistakon contact lenses include UV blocking properties to help protect against transmission of harmful UV radiation to the cornea and into the eye. They are available in both clear and visibility tinted options with UV blocker.
Are there different models available for different vision needs?
Yes, the Vistakon contact lens system includes spherical, multifocal, toric, and multifocal-toric designs to address various vision correction needs. The toric and multifocal-toric models can address higher levels of astigmatism up to 10.00D.