Acuvue 2 (Etafilcon A) Contact Lens, UV Blocker Tinted
by Johnson & Johnson Vision Care, Inc.
510(k) K010114
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010114 | Date11 Apr 2001 | 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- Withdrawn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
- Full name
- Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color)
- 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, designed for daily disposable use. It features a tinted UV blocker to mask or enhance the natural iris color while providing optical correction. The lens is formulated with etafilcon A, a silicone hydrogel material, to ensure comfort and oxygen permeability during wear.
The Acuvue 2 lenses are intended for single-use and must be discarded after removal. They are supplied sterile in sealed blister packs, requiring no cleaning or storage solution. The device is classified as Class II under FDA regulations and holds a 510(k) clearance for substantial equivalence in ophthalmic applications. Multiple product codes (e.g., 3015533540, 3012546757) correspond to various lens specifications, including diameter and base curve measurements.
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 use only?
These lenses are explicitly labeled as Daily Wear, meaning they are intended for continuous wear for up to 16 hours per day but must be removed and discarded after each use. They are not designed for extended wear (overnight use). Since they are single-use, each lens is intended for one day of wear only.
How are the lenses packaged, and do they require any special handling before use?
The lenses are supplied sterile in sealed blister packs, requiring no cleaning, storage solution, or additional preparation before use. Each pack is designed for single-use, and the blister packaging ensures sterility until opened. No additional handling (e.g., disinfection or rinsing) is necessary before insertion.
Can these tinted lenses be reused after removal, or are they strictly single-use?
These lenses are strictly single-use only—they must be discarded immediately after removal. The product description and FDA clearance explicitly state they are designed for daily disposable use, meaning each lens is intended for one day of wear and should not be reused.
What material are the lenses made from, and how does that affect comfort and oxygen permeability?
The lenses are made from etafilcon A, a silicone hydrogel material. This material is chosen for its high oxygen permeability, which helps maintain eye health during wear, and its comfortable, flexible properties. Silicone hydrogels are known for balancing moisture retention and oxygen transmission, making them suitable for daily wear.
Are there multiple sizes or base curve options available for these tinted contact lenses?
Yes, multiple product codes (e.g., 3015533540, 3012546757) correspond to different diameter and base curve measurements for these lenses. While the exact specifications (e.g., mm sizes) aren’t listed here, the variety of product codes indicates availability in various fits to accommodate different prescriptions and corneal shapes. Always verify the correct fit with an eye care professional.