FDA.report

Clareon

Primary DI
00380652412261
Brand
Clareon
Company
Alcon Laboratories, Inc.
Model
CNW0T8
Device description
Clareon Toric UVA
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HQLintraocular lens

Product Code Classifications

CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380652412261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652412261003806524122613806524122610380652412261

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. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Sterilization Methods

Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00380658544232Clareon TruPlusRECWT3RECWT3.0752026-03-23
00380658544249Clareon TruPlusRECWT3RECWT3.0802026-03-23
00380658544256Clareon TruPlusRECWT3RECWT3.0852026-03-23
00380658544263Clareon TruPlusRECWT3RECWT3.0902026-03-23
00380658544270Clareon TruPlusRECWT3RECWT3.0952026-03-23
00380658544287Clareon TruPlusRECWT3RECWT3.1002026-03-23
00380658544294Clareon TruPlusRECWT3RECWT3.1052026-03-23
00380658544300Clareon TruPlusRECWT3RECWT3.1102026-03-23
00380658544317Clareon TruPlusRECWT3RECWT3.1152026-03-23
00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
00380658544331Clareon TruPlusRECWT3RECWT3.1252026-03-23
00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
00380658544355Clareon TruPlusRECWT3RECWT3.1352026-03-23
00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
00380658544379Clareon TruPlusRECWT3RECWT3.1452026-03-23
00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23
00380658544416Clareon TruPlusRECWT3RECWT3.1652026-03-23
00380658544423Clareon TruPlusRECWT3RECWT3.1702026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05050474806153PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806177PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
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05050474806245PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806252PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806269PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806276PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806306PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806320PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806344PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806351PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806368PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806375PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806412PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806429PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806450PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806481PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806511PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806535PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806542PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806566PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806597PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806603PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806610PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806641PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806658PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806689PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474818736PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16