FDA.reportPublic FDA data

enVista Envy™ Toric IOL

Primary DI
10757770645142
Brand
enVista Envy™ Toric IOL
Company
Bausch & Lomb Incorporated
Model
ETN
Catalog number
ETNU500+330
Device description
enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +33.00D SE / +5.00D CYL
Published
2024-10-16
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

Product Codes#

Code, Name table
CodeName
MFKLens, Multifocal Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770645142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777064514210757770645142

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
05414846625238FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625245FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625252FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625269FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625276FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625283FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625290FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625306FINEVISION HP Trifocal IOLPhysiolMFK2026-06-04
05414846625313FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625320FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625337FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625344FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625351FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625368FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625375FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625382FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625399FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625405FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625412FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625429FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625436FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625443FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625450FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625467FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625474FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625481FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625498FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625504FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625511FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625528FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15