FreshKon® (Methafilcon A)

Basic Information

• Brand Name: FreshKon® (Methafilcon A)
• Primary DI: 08886428047382
• Version / Model: Alluring Eye, Mosaic,Colors Fusion
• Company Name: OCULUS PRIVATE LIMITED
• Labeler DUNS: 936888460
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3682b94f-8934-4cdd-84a6-08f0ed5eb2b5

Device Description

Two sterile daily wear soft contact lenses, 45% methafilcon A, 55% water, immersed in 0.9% buffered saline. Indication for use: The FreshKon® Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not‐aphakic persons with non‐diseased eyes. The lens may be disinfected using a chemical disinfection system. Eye Care Professionals may prescribe the lens for frequent replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE) When prescribed for frequent replacement wear,the lens may be disinfected using a chemical disinfection system.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47842	Soft corrective contact lens, daily-wear	A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08886428047382	GS1
Unit of Use	08886428047757	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14.2	Millimeter