Vistakon Galyfilcon A Soft Contact Lens
by Johnson & Johnson Vision Care, Inc. 510(k)
Active
510(k) K032340
Overview
The Vistakon Galyfilcon A Soft Contact Lens is a daily-wear, soft contact lens designed for vision correction. It is formulated with galyfilcon A, a silicone hydrogel material that balances oxygen permeability with comfort, enabling extended wear while maintaining corneal health.
These lenses are supplied as single-use or planned replacement options, with or without a visibility tint and UV blocker. They are intended for use in ophthalmic settings and have received FDA 510(k) clearance under the Traditional pathway. Multiple product codes (e.g., 3015533540, 3012546757) correspond to various lens specifications, including different diameters and powers, as regulated under 21 CFR 886.5925.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032340 | Date16 Oct 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1210-2018
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
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
Other devices from Johnson & Johnson Vision Care, Inc.
Questions
Are these lenses designed for continuous wear, or are they meant for daily use only?
The Vistakon Galyfilcon A lenses are formulated as daily-wear soft contact lenses, meaning they are intended for regular use during waking hours and should be removed at night. While the silicone hydrogel material (galyfilcon A) balances oxygen permeability for comfort, they are not labeled for extended or continuous wear beyond the standard daily-wear guidelines.
How are these lenses supplied, and do they come with any additional features like UV protection or a visibility tint?
These lenses are supplied as single-use or planned replacement options, depending on the specific product variant. Some versions include a visibility tint (to aid in lens insertion) and a UV blocker to protect the eyes from harmful ultraviolet rays. The exact features depend on the product code, so verifying the packaging or specifications is recommended.
Are these lenses reusable, or are they intended for one-time use?
The Vistakon Galyfilcon A lenses are available in both single-use and planned replacement formats. Single-use lenses are designed for one-time wear and disposal, while planned replacement options are intended for periodic replacement (e.g., monthly or biweekly) as specified by the manufacturer. Always follow the replacement schedule provided with the product.
What regulatory pathway was used for FDA clearance of these lenses, and what does that mean for their safety and equivalence?
These lenses received FDA 510(k) clearance under the Traditional pathway, meaning the manufacturer demonstrated that they are substantially equivalent to a legally marketed predicate device. This pathway ensures the lenses meet safety and effectiveness standards comparable to existing approved products, as determined by the FDA’s review process.
How should these lenses be stored, and is there any special handling required before use?
While the data does not specify storage instructions explicitly, standard practice for soft contact lenses typically involves storing them in a clean, dry, and sealed container (e.g., the original blister pack) away from moisture, heat, or direct sunlight. Always follow the manufacturer’s included instructions for optimal storage and handling to maintain sterility and performance.