Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives
510(k) K050065
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050065 | Date27 May 2005 | StatusActive |
Recalls
-
- Terminated Z-1402-06
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MVN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives are disposable contact lenses manufactured by Ciba Vision Corporation. These lenses are designed for daily wear and are available in various styles including toric and progressive options. The lenses are intended for ophthalmic use and are classified as Class II medical devices.
The Focus Dailies lenses are supplied as single-use disposable products and are not intended for reuse. They are authorized under FDA 510K clearance with K number K050065. The device is manufactured at the company's facility in Duluth, Georgia, and is regulated under product code MVN. No specific information regarding MRI safety, sterility, or storage conditions is provided in the device data.
Other devices from Ciba Vision Corporation
Questions
AI-generated answers, 27 Sep 2026
What are Focus Dailies contact lenses used for?
Focus Dailies are disposable contact lenses designed for daily wear and ophthalmic use. They are available in various styles including toric for astigmatism and progressive options for presbyopia, all intended for single-day use.
How are Focus Dailies contact lenses supplied?
Focus Dailies lenses are supplied as single-use disposable products and are not intended for reuse. They are manufactured by Ciba Vision Corporation at their facility in Duluth, Georgia.
What regulatory status do Focus Dailies contact lenses have?
Focus Dailies contact lenses are authorized under FDA 510K clearance with K number K050065. They are classified as Class II medical devices and regulated under product code MVN.
Are there different models available in the Focus Dailies line?
Yes, the Focus Dailies line includes three main options: standard Focus Dailies, Focus Dailies Toric for astigmatism correction, and Focus Dailies Progressives for presbyopia. Each is designed for daily wear and single-use disposal.