FDA.reportPublic FDA data

Infiniti

Primary DI
00380657521609
Brand
Infiniti
Company
Alcon Laboratories, Inc.
Model
8065752160
Device description
Infiniti Vision System
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQCUnit, phacofragmentation
HQEInstrument, vitreous aspiration and cutting, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380657521609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380657521609003806575216093806575216090380657521609

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification system generatorA mains electricity (AC-powered) ophthalmic device that generates the energy (e.g., ultrasonic, piezoelectric) in a cataract extraction system. The energy is delivered through a handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed for the removal of debris.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658439668ClareonCCW0T4CCW0T4-1052026-08-27
00380658439675ClareonCCW0T4CCW0T4-1102026-08-27
00380658439682ClareonCCW0T4CCW0T4-1152026-08-27
00380658439699ClareonCCW0T4CCW0T4-1202026-08-27
00380658439705ClareonCCW0T4CCW0T4-1252026-08-27
00380658439712ClareonCCW0T4CCW0T4-1302026-08-27
00380658439729ClareonCCW0T4CCW0T4-1352026-08-27
00380658439736ClareonCCW0T4CCW0T4-1402026-08-27
00380658439743ClareonCCW0T4CCW0T4-1452026-08-27
00380658439750ClareonCCW0T4CCW0T4-1502026-08-27
00380658439767ClareonCCW0T4CCW0T4-1552026-08-27
00380658439774ClareonCCW0T4CCW0T4-1602026-08-27
00380658439781ClareonCCW0T4CCW0T4-1652026-08-27
00380658439798ClareonCCW0T4CCW0T4-1702026-08-27
00380658439804ClareonCCW0T4CCW0T4-1752026-08-27
00380658439811ClareonCCW0T4CCW0T4-1802026-08-27
00380658439828ClareonCCW0T4CCW0T4-1852026-08-27
00380658439835ClareonCCW0T4CCW0T4-1902026-08-27
00380658439842ClareonCCW0T4CCW0T4-1952026-08-27
00380658439859ClareonCCW0T4CCW0T4-2002026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530274LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530281LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530298LEGION, INTREPIDAlcon Laboratories, Inc.HQC2026-07-22
00380657530373LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530502LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530564LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530755LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657531639LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531646LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531653LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531660LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07630003915709Oertli®Oertli-Instrumente AGHQC2024-10-15
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2022-07-01
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2022-07-01
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2021-06-11
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2021-06-11
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2021-06-11