FDA.reportPublic FDA data

SofPort LI61SE

Primary DI
10757770229694
Brand
SofPort LI61SE
Company
Bausch & Lomb Incorporated
Model
LI61SE1150
Catalog number
LI61SE1150
Device description
SQUARE EDGE SILICONE LENS11.5D
Published
2015-09-17
Public version status
Update
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
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770229694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075777022969410757770229694

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
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 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
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