FDA.reportPublic FDA data

ORA System® VerifEye™

Primary DI
00380659983306
Brand
ORA System® VerifEye™
Company
Alcon Laboratories, Inc.
Model
8065998330
Catalog number
8065998330
Device description
ORA System with VerifEye + Technology , Abberometer 195.5mmTransient, non-invasive, active therapeutic device, intended for diagnosis and monitoring in ophthalmic surgical procedure.
Published
2025-12-01
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
NCFAberrometer, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCFAberrometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380659983306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380659983306003806599833063806599833060380659983306

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.

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
00380659983290ORA System® VerifEye™Alcon Laboratories, Inc.NCF2025-12-01
10860009562803WaveDynWavefront Dynamics Inc.NCF2023-03-17
18437014903024HD AnalyzerVISIOMETRICS SLNCF2022-01-21
18437014903031TearFilm AnalyzerVISIOMETRICS SLNCF2022-01-21
00380657529995ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530007ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530014ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530038ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380657530939ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00380659983283ORA System® VerifEye™Alcon Laboratories, Inc.NCF2020-08-31
00860479001706Tracey-VFA Visual Function AnalyzerTRACEY TECHNOLOGIES, CORPORATIONNCF2020-01-09