FDA.reportPublic FDA data

Boston Equalens II

Primary DI
00785811435639
Brand
Boston Equalens II
Company
Bausch & Lomb Incorporated
Model
oprifocon A
Catalog number
Boston Equalens II
Device description
Rigid Gas Permeable Contact Lens
Published
2017-10-18
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
MWLLens,Contact(Rigid Gas Permeable)-Extended Wear
NUULens, Contact, Orthokeratology, Overnight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2
MWLLens, Contact (Rigid Gas Permeable), Extended WearOphthalmic3
NUULens, Contact, Orthokeratology, OvernightOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00785811435639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00785811435639007858114356397858114356390785811435639

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, extended-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 for continuous overnight wear for up to 7, 15, or 30 consecutive nights. 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
00850007135515Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135522Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135539Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135546Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000183Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000190Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000206Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000213Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000244Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000251Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000268Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000275Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000282Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000299Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000305Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000312Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000329Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000336Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000343Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000350Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099965Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099972Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099989Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099996Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135604Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135611Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501468Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501475Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501512Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501529Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05