FDA.reportPublic FDA data

OPTI-FREE REPLENISH

Primary DI
00300650356237
Brand
OPTI-FREE REPLENISH
Company
Alcon Laboratories, Inc.
Model
OPTI-FREE REPLENISH 2x14oz
Device description
Opti-Free Replenish Multi-Purpose Disinfecting Solution Twin Pack 2 x 14oz
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
K050729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050729000ALCON MULTI-PURPOSE DISINFECTING SOLUTIONAlcon Research, Ltd.2005-09-14LPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20300650356231PackageGS112In Commercial Distribution
20300650356255PackageGS112In Commercial Distribution
00300650356237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030065035623120300650356231
2030065035625520300650356255
00300650356237003006503562373006503562370300650356237

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose soft contact lens solutionA sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). 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
Kit
true
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