FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770473946
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
AI-28
Device description
Inserter
Published
2022-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00757770473946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770473946007577704739467577704739460757770473946

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA sterile, 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 plastic materials and 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

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
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