Intacs for Keratoconus, Symmetric 0.450 mm

Basic Information

• Brand Name: Intacs for Keratoconus, Symmetric 0.450 mm
• Primary DI: 00850048576155
• Version / Model: ICI-450-150
• Catalog Number: 11600-450-150
• Company Name: ADDITION TECHNOLOGY, INC.
• Labeler DUNS: 118496814
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: 692e596c-4cd7-4ecb-9cdb-6de3ef92629d

Device Description

Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LQE	Implant, Corneal, Refractive	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46903	Intracorneal ring segment	An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. It is typically a plastic arc, of about 150 degrees and provided in pairs, inserted into the cornea via an intrastromal channel created with a diamond knife or laser, and that can be implanted away from the radial incision to minimize complications. It is typically available in sizes from 0.25 to 0.35 mm. The device is intended to correct mild and moderate myopia and to treat patients with irregular astigmatism as a result of keratoconus, especially those who can no longer benefit from contact lenses or spectacles.	Yes	Active
36291	Intracorneal ring	An implantable, open-ended circular band designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct mild and moderate myopia. The device is inserted into the cornea via an intrastromal channel created with a diamond knife or laser. It is typically made of plastic, and has outer and inner diameters of about 8 and 6.8 mm, respectively.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850048576155	GS1

Premarket Submissions

Submission Number	Supplement Number
H040002	000