FDA.reportPublic FDA data

OPTI-FREE SUPRACLENS

Primary DI
00300650285445
Brand
OPTI-FREE SUPRACLENS
Company
Alcon Laboratories, Inc.
Model
OPTI-FREE SUPRACLENS 3ml
Device description
OPTI-FREE SUPRACLENS Daily Protein Remover 3ml
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPNAccessories, soft lens products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974625000OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVERAlcon Laboratories1998-03-04LPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20300650285449PackageGS124In Commercial Distribution
00300650285445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030065028544920300650285449
00300650285445003006502854453006502854450300650285445

GMDN Terms#

Term, Definition table
TermDefinition
Soft/rigid contact lens cleaning solutionAn aqueous formulation containing appropriate agents for loosening debris from reusable soft, rigid gas permeable (RGP), and hard contact lenses, often with a gentle rubbing of the lenses, to clean the lenses prior to wear. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)241-5999web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
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
00310119041062Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041086Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041420Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041468Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044230Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044247Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119304242up & up multipurpose solutionTARGET CORPORATIONLPN2026-01-09
00780707000007HydravueUnited Exchange Corp.LPN2025-05-23
00310119030189renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119030486renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031186renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031223renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119032220renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00194346415397EquateWAL-MART STORES, INC.LPN2024-12-05
00310119041307Target saline solution sensitive eyesTARGET CORPORATIONLPN2024-07-16
00310119304495up & up multipurpose solutionTARGET CORPORATIONLPN2024-07-16
00606492119079HydroPureOte North America LLCLPN2024-07-15
00606492119086HydroPureOte North America LLCLPN2024-07-10
00310119304501WalgreensWALGREEN CO.LPN2024-06-21
05060503857803Chromaview Multi-Purpose SolutionARCADANT B.V.LPN2024-05-22
00351801021016Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00351801021030Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00197644026180Clear ConscienceClear ConscienceLPN2024-03-21
00197644945504Clear Conscience Clear ConscienceLPN2024-03-21
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedLPN2023-10-25
00827444001512REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001529REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001536REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001550REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
30827444001513REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09