FDA.reportPublic FDA data

enVista Envy™ Toric IOL

Primary DI
10757770640710
Brand
enVista Envy™ Toric IOL
Company
Bausch & Lomb Incorporated
Model
ETN
Catalog number
ETNU150+130
Device description
enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +13.00D SE / +1.50D CYL
Published
2024-10-15
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
10757770640710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777064071010757770640710

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
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
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00380658490096Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490102Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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00380658490126Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490133Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490140Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490157Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490164Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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00380658490188Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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00380658490287Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490294Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490300Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490317Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490324Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490331Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490348Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490355Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01