FDA.reportPublic FDA data

EnVista MX60 IOL

Primary DI
10757770517005
Brand
EnVista MX60 IOL
Company
Bausch & Lomb Incorporated
Model
MX60TP200+145
Catalog number
MX60TP200+145
Device description
MX60TP200 12.5MM +14.5
Published
2015-09-18
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770517005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777051700510757770517005

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
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