FDA.reportPublic FDA data

EX-PRESS

Primary DI
00380650500045
Brand
EX-PRESS
Company
Alcon Laboratories, Inc.
Model
P-50
Catalog number
8065050004
Device description
EX-PRESS Glaucoma Filtration Device - Version P-50
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYFImplant, Eye Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYFImplant, Eye ValveOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380650500045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650500045003806505000453806505000450380650500045

GMDN Terms#

Term, Definition table
TermDefinition
Eye valveA sterile device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value (e.g., 8 to 10 mmHg). It is typically a very small (e.g., slit) valve implanted in the eye as a component of an eye stent, and typically used in patients with advanced glaucoma when, despite the use of medication, laser treatments, or a previous glaucoma filtration procedure (trabeculectomy), the addition of a drainage tube and valve (aqueous shunt) is recommended.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter50Micrometer

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888628047474XEN Glaucoma Treatment SystemAllergan, Inc.KYF2026-07-17
00892064002089Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00892064002096Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00853704002449iStent InfiniteGLAUKOS CORPORATIONKYF2022-10-19
00853704002470iStent infiniteGLAUKOS CORPORATIONKYF2022-10-05
00892064002188Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2020-08-12
00892064002348Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
00892064002355Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
10888628032439XEN Glaucoma Treatment SystemAllergan, Inc.KYF2018-01-30
00892064002126Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2017-09-08
00892064002119Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2016-11-16
09419196000014MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000021MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000038MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000052MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000069MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000076MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000083MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000090Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000106Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000212Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000229Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
00380650704931EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
00380650704948EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
05050474512993BAERVELDT GLAUCOMA IMPLANT (350)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513006BAERVELDT PARS PLANA GLAUCOMA IMPLANTJOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513013BAERVELDT GLAUCOMA IMPLANT (250)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
00892064002140Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002270Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002133Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24