FDA.reportPublic FDA data

EyeGility™ Inserter

Primary DI
10757770602497
Brand
EyeGility™ Inserter
Company
Bausch & Lomb Incorporated
Model
211027
Catalog number
211027
Device description
EyeGility inserter for preloaded enVista™ IOLs (2.4mm)
Published
2026-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770602497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777060249710757770602497

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
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