FDA.reportPublic FDA data

BLIS-X1

Primary DI
00757770520183
Brand
BLIS-X1
Company
Bausch & Lomb Incorporated
Model
BLIS-X1
Device description
BLIS IOL Delivery System – X1 Cartridge
Published
2024-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00757770520183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770520183007577705201837577705201830757770520183

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.

Regulatory Flags#

DUNS number
196603781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00757770425723Bausch + LombN1705 93N1705 932025-08-22
00757770420797Bausch + LombN2485N24852025-08-15
00757770423194Bausch + LombE3048E30482025-08-15
00757770407712Bausch + LombX0750 21X0750 212025-08-05
00757770683505Bausch + LombSP7-72199SP7-721992025-08-05
00757770424443Bausch + LombN6065 0N6065 02025-07-29
00757770429974Bausch + LombN6065 1N6065 12025-07-29
00757770430055Bausch + LombN6065 3N6065 32025-07-29
00757770404575Bausch + LombN0902N09022025-07-28
00757770405077Bausch + LombN0964N09642025-07-28
00757770406227Bausch + LombN0950N09502025-07-28
00757770408368Bausch + LombN0965N09652025-07-28
00757770409068Bausch + LombN0986N09862025-07-28
00757770417070Bausch + LombN0958N09582025-07-28
00757770420636Bausch + LombN0970N09702025-07-28
00757770426546Bausch + LombN0982N09822025-07-28
00757770411610Bausch + LombN1685 D 1N1685 D 12025-06-03
00757770523337BLIS-X0BLIS-X02024-03-04
00757770472222Bausch + LombMVS1083MVS10832016-09-24
00757770602506Bausch + LombET6322ET63222026-10-09

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
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
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