FDA.reportPublic FDA data

ACRYSOF®IQ RESTOR®

Primary DI
00380652241427
Brand
ACRYSOF®IQ RESTOR®
Company
Alcon Laboratories, Inc.
Model
SN6AD1
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
00380652241427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652241427003806522414273806522414270380652241427

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
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14
00380658552060Clareon TruPlusREYWT8REYWT8.2802026-05-14
00380658552077Clareon TruPlusREYWT8REYWT8.2852026-05-14
00380658552084Clareon TruPlusREYWT8REYWT8.2902026-05-14
00380658552091Clareon TruPlusREYWT8REYWT8.2952026-05-14
00380658552107Clareon TruPlusREYWT8REYWT8.3002026-05-14
00380658552114Clareon TruPlusREYWT8REYWT8.3102026-05-14
00380658552121Clareon TruPlusREYWT8REYWT8.3202026-05-14
00380658552138Clareon TruPlusREYWT8REYWT8.3302026-05-14
00380658552145Clareon TruPlusREYWT8REYWT8.3402026-05-14
00380658552152Clareon TruPlusREYWT9REYWT9.0602026-05-14
00380658552169Clareon TruPlusREYWT9REYWT9.0652026-05-14
00380658552176Clareon TruPlusREYWT9REYWT9.0702026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658490065Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490072Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490089Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490096Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490102Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490119Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490126Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490133Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490140Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490157Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490164Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490171Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490188Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490195Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490201Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490218Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490225Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490232Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490249Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490256Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490263Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490270Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490287Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490294Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490300Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490317Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490324Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490331Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490348Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490355Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01