FDA.reportPublic FDA data

enVista® Toric IOL

Primary DI
10757770568724
Brand
enVista® Toric IOL
Company
Bausch & Lomb Incorporated
Model
MX60PT
Catalog number
MXUPT500+120
Device description
enVista one-piece hydrophobic acrylic toric intraocular lens (preloaded) +12.00D 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
10757770568724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777056872410757770568724

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
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
10757770606495enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606501enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606518enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606525enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606532enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606549enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606563enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606570enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606587enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606594enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606600enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606617enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606624enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606631enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606648enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606655enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606662enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606679enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606686enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606693enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606709enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606716enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606723enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606730enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606747enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606754enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606761enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606778enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606785enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606792enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05