IC-8 Apthera IOL

Basic Information

• Brand Name: IC-8 Apthera IOL
• Primary DI: 00813359021073
• Version / Model: +27.0 D
• Catalog Number: 82078-270
• Company Name: ACUFOCUS, INC.
• Labeler DUNS: 138585281
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-04
• Public Version: 1
• Public Version Date: 2023-01-12
• Public Version Status: New
• Public Device Record Key: 797fb730-52c4-4a74-87b7-1c1b26755377

Device Description

One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.

Device Characteristics

• Single Use: Yes
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	886.3600	3

GMDN Terms

Code	Name	Definition	Implantable	Status
61210	Posterior-chamber intraocular lens, pseudophakic, extended-focus	A sterile optical device intended to be implanted into the posterior chamber of the eye to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. It consists of an intraocular lens (IOL) containing a small aperture inlay device designed to provide extended depth of focus for near vision, achieved through the pinhole effect. The components are typically made of synthetic polymer; disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813359021073	GS1

Premarket Submissions

Submission Number	Supplement Number
P210005	000