FDA.reportPublic FDA data

VISCOJECT 1.8 Injector Set

Primary DI
07630055214935
Brand
VISCOJECT 1.8 Injector Set
Company
Medicel AG
Model
LP604350
Catalog number
LP604350
Device description
Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070669000IOL INJECTOR SETMedicel AG2007-11-01KYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055214935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055214935076300552149357630055214935

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA 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 implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
0717271050info@MEDICEL.COM

Regulatory Flags#

DUNS number
487158263
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055213853VISCOJECT 2.2 Injector SetLP604340LP6043402026-04-24
07630055212023ACCUJECT 2.2-1P INJECTOR SETLP604530LP6045302025-12-09
07630055244055BICEL SOFT TIP I/A curved / 21G terralutionBIT21ASBIT21AS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PLP604590LP6045902025-09-30
07630055244031BICEL I/A curved / 21G terralutionBIT21A2025-05-28
07630055244048BICEL I/A curved / 23G terralutionBIT23A2025-05-28
07630055241863I/A Coaxial Handpiece Set Sophi - 20G/65°1401-22301401-22302024-11-28
07630055241870I/A Coaxial Handpiece Set Sophi - 21G/45°1401-22211401-22212024-11-28
07630055241887I/A Coaxial Handpiece Set Sophi - 23G/45°1401-22231401-22232024-11-28
07630055241894I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip1401-22431401-22432024-11-28
07630055243287I/A Bimanual Handpiece Set Sophi -21G/Aeroplane1401-21301401-21302024-11-28
07630055243959I/A Coaxial Handpiece Set Sophi - 20G/45°1401-22202024-11-28
07630055240835Phaco Accessory SetPA603901PA6039012023-12-01
07630055240859Phaco Accessory SetPA603903PA6039032023-12-01
07630055240866Phaco Accessory SetPA603904PA6039042023-12-01
07630055243744Phaco Accessory SetPA603951PA6039512023-12-01
07630055243751Phaco Accessory SetPA603952PA6039522023-12-01
07630055243768Phaco Accessory SetPA603953PA6039532023-12-01
07630055214850Accuject REFRA 2.9 InjectorREV.PAR29002023-12-08
07630055240217Swiss Coaxial I/ASMS355PSMS355P2023-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00380659777738MONARCH® IIIAlcon Laboratories, Inc.KYB2020-08-19
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