FDA.report

enVista MX60 IOL

Primary DI
10757770566843
Brand
enVista MX60 IOL
Company
Bausch & Lomb Incorporated
Model
MXUPT200+165
Catalog number
MXUPT200+165
Device description
MX60UPT200 12.5MM +16.50
Published
2020-07-17
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

Related Records

Product Codes

CodeName
HQLintraocular lens
NAALens, Intraocular, Accommodative

Product Code Classifications

CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3
NAALens, Intraocular, AccommodativeOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10757770566843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1075777056684310757770566843

GMDN Terms

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

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
false
Serial number
true
Manufacturing date on label
false
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 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 DIBrandCompanyProduct codePublished
05050474806153PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806177PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806207PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806214PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806238PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806245PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806252PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806269PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806276PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806306PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806320PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806344PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806351PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806368PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806375PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806412PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806429PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806450PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806481PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806511PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806535PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806542PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806566PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806597PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806603PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806610PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806641PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806658PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474806689PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16
05050474818736PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.HQL2026-03-16