FDA.reportPublic FDA data

enVista® Toric IOL

Primary DI
10757770568601
Brand
enVista® Toric IOL
Company
Bausch & Lomb Incorporated
Model
MX60PT
Catalog number
MXUPT500+060
Device description
enVista one-piece hydrophobic acrylic toric intraocular lens (preloaded) +6.00D SE / +5.00D CYL
Published
2020-07-18
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
HQLintraocular lens
NAALens, Intraocular, Accommodative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3
NAALens, Intraocular, AccommodativeOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770568601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777056860110757770568601

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Serial number
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
10757770096746PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096760PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096784PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096807PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096821PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096845PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096869PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096883PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096906PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096920PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096944PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096951PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096968PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096975PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096982PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770096999PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097002PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097019PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097026PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097033PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097040PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097057PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097064PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097071PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097088PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097095PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097101PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097118PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097125PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17
10757770097132PMMA (P359UV)Bausch & Lomb IncorporatedHQL2015-09-17