FDA.reportPublic FDA data

Boston ES

Primary DI
00785811435684
Brand
Boston ES
Company
Bausch & Lomb Incorporated
Model
enflufocon A
Catalog number
Boston ES
Device description
Rigid Gas Permeable Contact Lens
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00785811435684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00785811435684007858114356847858114356840785811435684

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wearA rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850203008040AcuityACUITY POLYMERS, INC.HQD2025-06-09
00850203008330AcuityACUITY POLYMERS, INC.HQD2025-06-09
00860011844129Custom StableValley Contax, Inc.HQD2025-03-14
00860011844136Custom StableValley Contax, Inc.HQD2025-03-14
06974939049000SDJMASTERVISIONTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049017EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049024EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049031EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049048EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
00860011844105Custom Stable Valley Contax, Inc.HQD2024-04-08
00860011844112Custom StableValley Contax, Inc.HQD2024-04-08
B22225Oxfore100Paragon Vision Sciences, Inc.HQD2023-09-18
00865576000249Optimum HR 1.51CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000256Optimum HR 1.53CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000270Hybird FSCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000294Optimum InfiniteCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000201Optimum ExtraCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000225Optimum ComfortCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000232Optimum ClassicCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000287HEXA100CONTAMAC HOLDINGS LIMITEDHQD2020-07-22
B22204Fluoroperm 92Paragon Vision Sciences, Inc.HQD2018-03-23
B22205Fluoroperm 60Paragon Vision Sciences, Inc.HQD2018-03-23
B22206Fluoroperm 30Paragon Vision Sciences, Inc.HQD2018-03-23
B22207Fluoroperm 151Paragon Vision Sciences, Inc.HQD2018-03-23
B22208Paragon HDSParagon Vision Sciences, Inc.HQD2018-03-23
B22209Paragon HDS100Paragon Vision Sciences, Inc.HQD2018-03-23
B22212Paragon ThinParagon Vision Sciences, Inc.HQD2018-03-23
B22211FSA 38Paragon Vision Sciences, Inc.HQD2018-03-16
B22214FSA 52Paragon Vision Sciences, Inc.HQD2018-03-16