FDA.reportPublic FDA data

Cypass

Primary DI
00380657540075
Brand
Cypass
Company
Alcon Laboratories, Inc.
Model
8065754007
Device description
CYPASS ULTRA SYSTEM CYPASS MICRO-STENT CYPASS' APPLIER
Published
2018-07-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGOIntraocular pressure lowering implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGOIntraocular Pressure Lowering ImplantUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150037008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150037008CyPass Micro-StentAlcon Research, Ltd.2016-07-29OGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380657540075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380657540075003806575400753806575400750380657540075

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma shuntA sterile, non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853704002487iStent inject W Trabecular Micro-Bypass System with Infinite Injector TechnologyGLAUKOS CORPORATIONOGO2025-04-30
00853704002319iStent inject WGLAUKOS CORPORATIONOGO2020-08-11
00867487000134Hydrus® MicrostentAlcon Laboratories, Inc.OGO2018-08-15
20867487000138Hydrus® MicrostentIVANTIS, INC.OGO2018-08-15
00853704002203iStent injectGLAUKOS CORPORATIONOGO2018-07-25
00380657540037CyPassAlcon Laboratories, Inc.OGO2016-09-16
10380657540034CyPassAlcon Laboratories, Inc.OGO2016-09-16
00853704002005iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002012iStentGLAUKOS CORPORATIONOGO2015-09-21
00853704002029iStentGLAUKOS CORPORATIONOGO2015-09-21