Paragon CRT Dual Axis

Basic Information

• Brand Name: Paragon CRT Dual Axis
• Primary DI: B22219
• Version / Model: Paragon CRT Dual Axis
• Company Name: Paragon Vision Sciences, Inc.
• Labeler DUNS: 028594987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-05
• Public Version: 1
• Public Version Date: 2021-04-13
• Public Version Status: New
• Public Device Record Key: 8e4f94a5-3991-49c6-a590-ea3d27ac5233

Device Description

Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: the central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon CRT Dual Axis® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic	886.5916	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47926	Orthokeratology contact lens	A rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit 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	B22219	HIBCC