FDA.reportPublic FDA data

ACRYSOF, IQ RESTOR

Primary DI
00380652268899
Brand
ACRYSOF, IQ RESTOR
Company
Alcon Laboratories, Inc.
Model
SND1T3
Catalog number
SND1T3U130
Device description
Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Published
2017-02-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MFKLENS, MULTIFOCAL INTRAOCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380652268899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652268899003806522688993806522688990380652268899

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658526047Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-27
00380658528225Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-27
00380658530839Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-27
00380658527983Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658527990Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658528003Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529086Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529093Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529109Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529116Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529123Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529130Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529147Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529154Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529161Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529178Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529185Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529192Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529208Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529215Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529222Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529239Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529246Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529253Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529260Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529277Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529284Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529291Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529307Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26
00380658529314Clareon PanOptix ProAlcon Laboratories, Inc.MFK2026-08-26