FDA.reportPublic FDA data

ACCUJECT injector Set 2.1-1P

Primary DI
07630055214584
Brand
ACCUJECT injector Set 2.1-1P
Company
Medicel AG
Model
LP604590
Catalog number
LP604590
Device description
The ACCUJECT IOL injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.
Published
2025-09-30
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
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252540000ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG2025-09-16MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055214584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055214584076300552145847630055214584

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
+41717270969info@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
07630055214935VISCOJECT 1.8 Injector SetLP604350LP6043502026-04-28
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
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
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344796MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300013MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300020MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00841668142851ASICO ROYALE III INJECTOR W/ LONG SPRINGKATENA PRODUCTS, INC.MSS2022-12-13
00841668142868ASICO ROYALE III INJECTORKATENA PRODUCTS, INC.MSS2022-12-13