FDA.reportPublic FDA data

ACRYSOF® RESTOR®

Primary DI
00380652307505
Brand
ACRYSOF® RESTOR®
Company
Alcon Laboratories, Inc.
Model
SV25T0
Device description
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00380652307505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652307505003806523075053806523075050380652307505

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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