FDA.report

AcrySof® ReSTOR® Aspheric UV Absorbing TORIC IOL

Primary DI
00380652349406
Brand
AcrySof® ReSTOR® Aspheric UV Absorbing TORIC IOL
Company
Alcon Laboratories, Inc.
Model
SA25T6
Catalog number
SA25T6U230
Device description
Sterile UV Absorbing Hydrophobic Acrylic Foldable Single-piece Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens
Published
2018-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MFKLENS, MULTIFOCAL INTRAOCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380652349406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652349406003806523494063806523494060380652349406

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

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