FDA.reportPublic FDA data

PolyVue HD Dailies

Primary DI
08806392000770
Brand
PolyVue HD Dailies
Company
INTEROJO INC.
Model
HD Dailies
Published
2019-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVNLens, Contact, (Disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVNLens, Contact, (Disposable)Ophthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153766000Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily WearINTEROJO, Inc.2016-04-08LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806392000770PrimaryGS10
08806392000787Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806392000770088063920007708806392000770
08806392000787088063920007878806392000787

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-disposableA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-760-754-2220rho@interojo.com

Regulatory Flags#

DUNS number
688455799
Device count
90
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809752409763HAPA KRISTINOn Vacation Kristin Blue Trial /-00.00 2025-04-18
08809752409770HAPA KRISTINSoft Haze Kristin Hazel Trial /-00.00 2025-04-18
08809752409787HAPA KRISTINPlayful Kristin Blue Trial /-00.00 2025-04-18
08809752409794HAPA KRISTINPlayful Kristin Gray Trial /-00.00 2025-04-18
08800245547405MizMiz/Aqua2024-09-24
08800245547412MizMiz/Dark Gray2024-09-24
08800245547429MizMiz/Trinity Gray2024-09-24
08800245547436MizMiz/Mint Green2024-09-24
08800245547443MizMiz/Honey2024-09-24
08800245547450MizMiz/Jade2024-09-24
08800245547467MizMiz/Angel Violet2024-09-24
08800245547474MizMiz/Sunset Brown 2024-09-24
08800245547481MizMiz/Fiesta Gray2024-09-24
08800245547498MizMiz/Chestnut Brown2024-09-24
08800245547504MizMiz/Marble Gray2024-09-24
08800245547511MizMiz/Twilight Hazel2024-09-24
08800245547528MizMiz/Serenity Brown2024-09-24
08800245547535MizMiz/Angel Gray2024-09-24
08800245547542MizMiz/Honey Hazel2024-09-24
08800245547559MizMiz/Topaz Hazel2024-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686573611COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573628COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573635COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573642COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573659COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573666COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573673COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573680COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573697COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573703COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573710COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573727COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573734COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573741COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573758COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573765COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573772COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573789COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573796COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573802COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573819COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573826COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573833COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573840COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573857COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573864COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573871COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573888COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573895COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16
06942686573901COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-16