FDA.reportPublic FDA data

Lens Exchange Sytem

Primary DI
M687PR104013
Brand
Lens Exchange Sytem
Company
VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
Model
G25
Catalog number
PR00104-01
Device description
Lens Exchange System LES G25 three unit package
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYBLens, Guide, Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYBLens, Guide, IntraocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M687PR104013PrimaryHIBCC0
M687PR104001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens implantation cordA sterile device intended to be attached to, and enable temporary extension of, the haptic loops of an intraocular lens (IOL) to facilitate implantation of the IOL in the posterior chamber of the eye. It typically includes two lengths of cord with connectors and a mounting tray. It is often used during IOL replacement as an alternative to IOL injection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store the device in direct sunlight
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity20 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius43 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius0 Degrees Celsius

Regulatory Flags#

DUNS number
532007614
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M687PR00018000Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)WA 2.2XPR00018-002014-09-18
M687PR00020000Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)WA 2.7XPR00020-002014-09-18
M687PR103013Lens Exchange SytemG23PR00103-012017-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055214935VISCOJECT 1.8 Injector SetMedicel AGKYB2026-04-28
07630055213853VISCOJECT 2.2 Injector SetMedicel AGKYB2026-04-24
00194613086435MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-08-01
00194613123147MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-03-21
00840311344796MicroStaarSTAAR SURGICAL COMPANYKYB2023-06-15
05055313817222Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313818922Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313820901Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313821632Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313822295Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
00757770473946Bausch + LombBausch & Lomb IncorporatedKYB2022-02-25
00380659777738MONARCH® IIIAlcon Laboratories, Inc.KYB2020-08-19
00380659777578MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777585MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777639MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
10380659777575MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777582MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777636MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
00813465011135IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
00813465011142IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011166IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011173Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
00813465011180Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
10813465011132IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
10813465011149IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011163IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011170Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
10813465011187Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
00813465012071Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05
00813465012101IOL Glide - SheetsHURRICANE MEDICAL INCKYB2020-05-05