Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Basic Information

• Brand Name: Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
• Primary DI: 06975326567787
• Version / Model: BARBIE
• Company Name: Shenzhen Dashicheng Optical Technology Co., Ltd.
• Labeler DUNS: 543028405
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-22
• Public Version: 1
• Public Version Date: 2023-05-30
• Public Version Status: New
• Public Device Record Key: d9105a1a-a341-4f51-a4bc-9e4257431a7d

Device Description

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Device Characteristics

• Single Use: Yes
• 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
MVN	Lens, Contact, (Disposable)	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47841	Soft corrective contact lens, daily-disposable	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 (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975326567787	GS1

Premarket Submissions

Submission Number	Supplement Number
K220143	000