Paragon Z CRT Dual Axis

GUDID B22222

Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). 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 Z 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 lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.

Paragon Vision Sciences, Inc.

Orthokeratology contact lens

• Primary Device ID: B22222
• NIH Device Record Key: 3c91b0d3-4142-4788-b4d7-856fcdc9d2f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon Z CRT Dual Axis
• Version Model Number: Paragon Z CRT Dual Axis
• Company DUNS: 028594987
• Company Name: Paragon Vision Sciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B22222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050031

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

Devices Manufactured by Paragon Vision Sciences, Inc.

• B22225 - Oxfore100: 2023-09-26 The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut int
• B22217 - Paragon CRT: 2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anter
• B22218 - Paragon CRT100: 2021-04-13 Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congru
• B22219 - Paragon CRT Dual Axis: 2021-04-13 Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon C
• B22220 - Paragon RG-4: 2021-04-13 Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consist
• B22221 - Paragon Z CRT: 2021-04-13 Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterio
• B22222 - Paragon Z CRT Dual Axis: 2021-04-13Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). 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 Z 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 lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
• B22222 - Paragon Z CRT Dual Axis: 2021-04-13 Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congrue
• B22202 - Paraperm O2: 2019-05-06 Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact