FDA.reportPublic FDA data

MONARCH® III

Primary DI
00380659777738
Brand
MONARCH® III
Company
Alcon Laboratories, Inc.
Model
8065977773
Device description
MONARCH III IOL DELIVERY SYSTEM, INJECTOR
Published
2020-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00380659777738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380659777738003806597777383806597777380380659777738

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, reusableA hand-held, manual, ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of lightweight metal materials [e.g., titanium (Ti)], has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055214935VISCOJECT 1.8 Injector SetMedicel AGKYB2026-04-28
07630055213853VISCOJECT 2.2 Injector SetMedicel AGKYB2026-04-24
00194613086435MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-08-01
00194613123147MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-03-21
00840311344796MicroStaarSTAAR SURGICAL COMPANYKYB2023-06-15
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
00380659777578MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777585MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777639MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
10380659777575MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777582MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777636MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
00813465011135IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
00813465011142IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011166IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011173Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
00813465011180Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
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
00813465012071Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05
00813465012101IOL Glide - SheetsHURRICANE MEDICAL INCKYB2020-05-05
10813465012078Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05