Optacryl 60

Basic Information

• Brand Name: Optacryl 60
• Primary DI: B22201
• Version / Model: Optacryl 60
• Company Name: Paragon Vision Sciences, Inc.
• Labeler DUNS: 028594987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-24
• Public Version: 4
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 99ecc4f4-eba0-48bc-8648-303551e10cf0

Device Description

Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and posterior surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Optacryl® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The lens material is available in blue, green, or gray versions. The blue lens contains Microlith Blue 4 G-K; the green lens contains Sunfast Green No. 7; and, the gray lens contains D&C Green No. 6, D&C Violet No. 2, and Perox Yellow No. 9 as the color additives.

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: 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
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	886.5916	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47840	Rigid-gas-permeable corrective contact lens, daily-wear, non-customized	A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. 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
Package	B222010	HIBCC	vial	1	In Commercial Distribution
Primary	B22201	HIBCC