FDA.reportPublic FDA data

AcrySof®

Primary DI
00380652338943
Brand
AcrySof®
Company
Alcon Laboratories, Inc.
Model
SA6AT9
Catalog number
SA6AT9.200
Device description
AcrySof® Aspheric UV Absorbing Toric Posterior Chamber Intraocular Lens (IOL)
Published
2021-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQLintraocular lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380652338943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652338943003806523389433806523389430380652338943

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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10757770606549enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
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10757770606570enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
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10757770606785enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606792enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05