Alcon AcrySof®

Basic Information

• Brand Name: Alcon AcrySof®
• Primary DI: 00380659909467
• Version / Model: Version 3
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-13
• Public Version: 4
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 0d3a82fc-6ed1-4969-8950-0c87bab08972

Device Description

AcrySof® IQ Toric IOL Calculator

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: No
• 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
HQL	intraocular lens	Ophthalmic	886.3600	3

GMDN Terms

Code	Name	Definition	Implantable	Status
52847	Intraocular lens calculation software	A stand-alone software application designed to assist a surgeon in the selection and placement of an intraocular lens (IOL) by performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected. It is designed to be installed on an off-the-shelf computer/smart device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380659909467	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]