FDA.reportPublic FDA data

enVista Envy™ Toric IOL

Primary DI
10757770640444
Brand
enVista Envy™ Toric IOL
Company
Bausch & Lomb Incorporated
Model
ETN
Catalog number
ETNU125+285
Device description
enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +28.50D SE / +1.25D 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
OTC
false
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
10757770640444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777064044410757770640444

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658490065Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490072Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490089Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490096Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490102Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490119Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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
00380658490171Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490188Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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00380658490263Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
00380658490270Clareon PanOptix ProAlcon Laboratories, Inc.MFK2025-04-01
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