FDA.reportPublic FDA data

REFRESH CONTACTS® Contact Lens Comfort Drops

Primary DI
00300231822120
Brand
REFRESH CONTACTS® Contact Lens Comfort Drops
Company
Allergan, Inc.
Model
91822US
Catalog number
91822US
Device description
REFRESH CONTACTS® Contact Lens Comfort Drops
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
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
K992028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992028000REFRESH CONTACTS LUBRICATING AND REWETTING DROPSAllergan, Inc.1999-10-07LPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00300231822120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00300231822120003002318221203002318221200300231822120

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens wetting solutionAn aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006781605ProductSupport@allergan.com

Regulatory Flags#

DUNS number
144796497
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888628031432Natrelle Inspira ST Resterilizable SizersMSZST-L110MSZST-L1102016-10-04
10888628031449Natrelle Inspira ST Resterilizable SizersMSZST-L125MSZST-L1252016-10-04
10888628031456Natrelle Inspira ST Resterilizable SizersMSZST-L140MSZST-L1402016-10-04
10888628031463Natrelle Inspira ST Resterilizable SizersMSZST-L170MSZST-L1702016-10-04
10888628031470Natrelle Inspira ST Resterilizable SizersMSZST-L200MSZST-L2002016-10-04
10888628031487Natrelle Inspira ST Resterilizable SizersMSZST-L230MSZST-L2302016-10-04
10888628031494Natrelle Inspira ST Resterilizable SizersMSZST-L260MSZST-L2602016-10-04
10888628031500Natrelle Inspira ST Resterilizable SizersMSZST-L290MSZST-L2902016-10-04
10888628031517Natrelle Inspira ST Resterilizable SizersMSZST-L320MSZST-L3202016-10-04
10888628031524Natrelle Inspira ST Resterilizable SizersMSZST-L350MSZST-L3502016-10-04
10888628031531Natrelle Inspira ST Resterilizable SizersMSZST-L380MSZST-L3802016-10-05
10888628031548Natrelle Inspira ST Resterilizable SizersMSZST-L410MSZST-L4102016-10-05
10888628031555Natrelle Inspira ST Resterilizable SizersMSZST-L460MSZST-L4602016-10-05
10888628031562Natrelle Inspira ST Resterilizable SizersMSZST-L510MSZST-L5102016-10-05
10888628031579Natrelle Inspira ST Resterilizable SizersMSZST-L560MSZST-L5602016-10-05
10888628031586Natrelle Inspira ST Resterilizable SizersMSZST-L610MSZST-L6102017-03-20
10888628031593Natrelle Inspira ST Resterilizable SizersMSZST-LP125MSZST-LP1252016-10-05
10888628031609Natrelle Inspira ST Resterilizable SizersMSZST-LP145MSZST-LP1452016-10-05
10888628031616Natrelle Inspira ST Resterilizable SizersMSZST-LP165MSZST-LP1652016-10-05
10888628031623Natrelle Inspira ST Resterilizable SizersMSZST-LP190MSZST-LP1902016-10-05

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