AccessGUDID - DEVICE: Paragon Z CRT Dual Axis (B22222)

GUDID

Device Identifier (DI) Information

Brand Name: Paragon Z CRT Dual Axis
Version or Model: Paragon Z CRT Dual Axis
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paragon Vision Sciences, Inc.

Primary DI Number: B22222
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028594987 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUU	Lens, Contact, Orthokeratology, Overnight

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c91b0d3-4142-4788-b4d7-856fcdc9d2f6
Public Version Date: November 06, 2023
Public Version Number: 2
DI Record Publish Date: April 05, 2021