FDA.reportPublic FDA data

ProOcular Daily Disposable Contact Lens

Primary DI
40816816880617
Brand
ProOcular Daily Disposable Contact Lens
Company
CARLSBAD TECHNOLOGY INC.
Model
-8
Device description
ProOcular Daily Disposable Contact Lens Power -8
Published
2016-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30816816880610PackageGS124Not in Commercial Distribution
40816816880617PackageGS16Not in Commercial Distribution
10816816880616PrimaryGS10
00816816880619Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081681688061030816816880610
4081681688061740816816880617
1081681688061610816816880616
00816816880619008168168806198168168806190816816880619

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 Temperature46 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-397-9777service@carlsbadtech.com

Regulatory Flags#

DUNS number
079113545
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816816880395ProOcular Daily Disposable Contact Lens-1.52016-10-28
10816816880401ProOcular Daily Disposable Contact Lens-1.752016-10-28
10816816880418ProOcular Daily Disposable Contact Lens-22016-10-28
10816816880425ProOcular Daily Disposable Contact Lens-2.252016-10-28
10816816880432ProOcular Daily Disposable Contact Lens-2.52016-10-28
10816816880449ProOcular Daily Disposable Contact Lens-2.752016-10-28
10816816880456ProOcular Daily Disposable Contact Lens-32016-10-28
10816816880463ProOcular Daily Disposable Contact Lens-3.252016-10-28
10816816880470ProOcular Daily Disposable Contact Lens-3.52016-10-28
10816816880487ProOcular Daily Disposable Contact Lens-3.752016-10-28
10816816880494ProOcular Daily Disposable Contact Lens-42016-10-28
10816816880500ProOcular Daily Disposable Contact Lens-4.252016-10-28
10816816880517ProOcular Daily Disposable Contact Lens-4.52016-10-28
10816816880524ProOcular Daily Disposable Contact Lens-4.752016-10-28
10816816880531ProOcular Daily Disposable Contact Lens-52016-10-28
10816816880548ProOcular Daily Disposable Contact Lens-5.252016-10-28
10816816880555ProOcular Daily Disposable Contact Lens-5.52016-10-28
10816816880562ProOcular Daily Disposable Contact Lens-5.752016-10-28
10816816880579ProOcular Daily Disposable Contact Lens-62016-10-28
10816816880586ProOcular Daily Disposable Contact Lens-6.52016-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686584549coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584556coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584563coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584570coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584587coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584594coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584600coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584617coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584624coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584631coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584648coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584655coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584662coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584679coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584686coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584693coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584709coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584716coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584723coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584730coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584747coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584754coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584761coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584778coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584785coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584792coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584808coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584815coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584822coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18
06942686584839coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-09-18