MONARCH® II

Primary DI
10380659777582
Brand
MONARCH® II
Company
Alcon Laboratories, Inc.
Model
8065977758
Device description
The Monarch® "B" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery
Published
2020-05-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYBLENS, GUIDE, INTRAOCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYBLens, Guide, IntraocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380659777582PackageGS110In Commercial Distribution
00380659777585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065977758210380659777582
00380659777585003806597775853806597775850380659777585

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens-insertion cartridgeA sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613086435MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-08-01
00194613123147MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-03-21
05055313817222Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313818922Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313820901Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313821632Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313822295Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
00757770473946Bausch + LombBausch & Lomb IncorporatedKYB2022-02-25
00380659777738MONARCH® IIIAlcon Laboratories, Inc.KYB2020-08-19
10380659777575MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777636MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
10813465011132IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
10813465011149IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011163IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011170Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
10813465011187Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
10813465012078Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05
10813465012108IOL Glide - SheetsHURRICANE MEDICAL INCKYB2020-05-05
15050474500126UNFOLDER EMERALDJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474523491UNFOLDER SILVERJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474534503UNFOLDER EMERALDJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474530024UNFOLDER EMERALDJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474530031UNFOLDER SILVERJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474534466UNFOLDER EMERALD ARJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474534602ONE SERIES ULTRAJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13
15050474540320UNFOLDER PLATINUM 1 SERIESJOHNSON & JOHNSON SURGICAL VISION, INC.KYB2019-02-13