FDA.reportPublic FDA data

VERION™

Primary DI
00380659982682
Brand
VERION™
Company
Alcon Laboratories, Inc.
Model
8065998268
Device description
VERION™ Reference Unit
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFGDevice, communications, images, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFGDevice, Communications, Images, OphthalmicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380659982682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380659982682003806599826823806599826820380659982682

GMDN Terms#

Term, Definition table
TermDefinition
Bench-top keratometerA bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer.

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
Premarket exempt
true
Serial number
true
Manufacturing 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
00627987702149Optina FotysOptina Diagnostiques, IncNFG2025-08-29
04260284390013Navilas® Laser System 577sOD-OS GmbHNFG2023-11-21
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFG2023-06-12
08720892096401Cassini Guidance SystemCassini Technologies B.V.NFG2023-05-08
04549292182729CANON INC.CANON INC.NFG2020-10-16
00380659982699VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982705VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982811VERION™Alcon Laboratories, Inc.NFG2020-08-31
04049471100020FORUM Viewer AppCarl Zeiss Meditec AGNFG2018-03-22
04987669100523Image filing softwareNIDEK CO.,LTD.NFG2016-08-26
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFG2016-06-24
03596010589637INTEGRATION BROKERSmith & Nephew, Inc.NFG2016-04-12
03596010588371N/ASmith & Nephew, Inc.NFG2016-04-12
04049471094077VISUPAC 500Carl Zeiss Meditec AGNFG2016-01-15
03596010588388INTEGRATION BROKERSmith & Nephew, Inc.NFG2015-08-29