Vistakon Narafilcon B Contact Lens Visibility Tinted With UV Blocker
by Johnson & Johnson Vision Care, Inc.
510(k) K100349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100349 | Date21 May 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
This device is a Soft Contact Lens, Daily Wear, classified under FDA device class 2. It is designed as a silicone hydrogel contact lens with an internal wetting agent, featuring spherical, multifocal, toric, and toric-multifocal designs. The lens incorporates a blue visibility tint and a benzotriazole UV-absorbing monomer to enhance visibility and block ultraviolet radiation.
The lens is supplied as a single-use, daily-wear product intended for ocular use. It is regulated under FDA 510(k) clearance (K100349) and falls under the ophthalmic medical specialty. The visibility tint aids in handling, while the UV-blocking properties protect the eye from harmful ultraviolet light. Multiple registration numbers and FEI numbers are associated with its regulatory filing.
Other devices from Johnson & Johnson Vision Care, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for extended wear, or are they meant for daily wear only?
These lenses are explicitly labeled as daily-wear only, meaning they are intended for continuous wear during waking hours but must be removed before sleeping. The product description confirms they are not designed for extended or overnight wear.
What types of vision correction do these lenses address, and how do they differ from standard single-vision lenses?
These Vistakon (Narafilcon B) lenses come in spherical, multifocal, toric, and toric-multifocal designs, addressing presbyopia (multifocal), astigmatism (toric), and combinations of both (toric-multifocal). Unlike standard single-vision lenses, they provide additional optical correction for multiple focal distances or irregular corneal shapes, improving vision clarity for complex refractive errors.
How are these lenses packaged, and are they single-use or reusable?
The lenses are supplied as single-use, meaning each lens is intended for one-day wear and disposal. This aligns with the daily-wear classification and ensures hygiene and safety for ocular use, as reusable lenses would require cleaning and maintenance, which is not applicable here.
Do these lenses include any special features to enhance visibility or protect the eyes, and how do they work?
Yes, these lenses feature a blue visibility tint to improve handling and visibility during insertion/removal, and a benzotriazole UV-blocking monomer that absorbs ultraviolet radiation (UVA/UVB), protecting the eye from harmful UV exposure. The tint aids users in locating the lens, while the UV blocker provides an additional layer of ocular protection.
What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians or buyers?
The device was cleared through the FDA 510(k) pathway (K100349), specifically under the Traditional Review process, with a determination of Substantially Equivalent (SE) to a predicate device. This means the FDA reviewed the data to confirm the lens meets established safety and effectiveness standards for Soft Contact Lenses, Daily Wear (Class II). Clinicians or buyers can rely on this clearance as evidence of regulatory scrutiny for performance, materials, and intended use.