FDA.reportPublic FDA data

Ocylens

Primary DI
00811059034072
Brand
Ocylens
Company
WESTERN BIOTECH LLC
Model
01
Device description
1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
Published
2018-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811059034072PrimaryGS10
10811059034079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811059034072008110590340728110590340720811059034072
1081105903407910811059034079

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
206-395-8996contact@westernbiotech.com

Regulatory Flags#

DUNS number
081063873
Device count
120
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811059034041Ocylens012018-07-27
00811059034058Ocylens012018-07-27
00811059034065Ocylens012018-07-27
00811059034089Ocylens012018-07-27
00811059034096Ocylens012018-07-27
00811059034102Ocylens012018-07-27
00811059034119Ocylens012018-07-27
00811059034126Ocylens012018-07-27
00811059034133Ocylens012018-07-27
00811059034140Ocylens012018-07-27
00811059034157Ocylens012018-07-27
00811059034164Ocylens012018-07-27
00811059034171Ocylens012018-07-27
00811059034188Ocylens012018-07-27
00811059034195Ocylens012018-07-27
00811059034201Ocylens012018-07-27
00811059034218Ocylens012018-07-27
00811059034225Ocylens012018-07-27
00811059034232Ocylens012018-07-27
00811059034249Ocylens012018-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942686575905coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575912coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575929coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575936coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575943coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575950coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575967coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575974coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575981coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575998coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576001coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576018coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576025coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576032coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576049coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576056coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576063coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576070coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576087coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576094coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576100coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576117coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576124coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576131coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576148coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576155coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576162coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576179coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576186coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576193coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17