FDA.reportPublic FDA data

ClearView 3

Primary DI
00844369038096
Brand
ClearView 3
Company
Lenstec Barbados Inc
Model
SBL-3+14.5
Catalog number
SBL-3
Device description
Multifocal IOL modified plate, HEMA
Published
2023-01-25
Public version status
New
Distribution status
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
MFKLens, Multifocal Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200020000SBL-3 Multifocal Intraocular LensLenstec, Inc.2022-07-22MFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844369038096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844369038096008443690380968443690380960844369038096

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18665367832feedback@lenstec.com

Regulatory Flags#

DUNS number
860235001
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844369016858I9011S05-21352024-05-06
00844369016865I901205-2136-B2024-05-06
00844369016872I9012FS05-2138-B2024-05-06
00844369018944LC16LC162024-05-06
00844369018968LC24LC242024-05-06
00844369018975CART45SCART45S2024-05-06
00844369018982CARTMCARTM2024-05-06
00844369038003ClearView 3SBL-3+10.0SBL-32023-01-25
00844369038010ClearView 3SBL-3+10.5SBL-32023-01-25
00844369038027ClearView 3SBL-3+11.0SBL-32023-01-25
00844369038034ClearView 3SBL-3+11.5SBL-32023-01-25
00844369038041ClearView 3SBL-3+12.0SBL-32023-01-25
00844369038058ClearView 3SBL-3+12.5SBL-32023-01-25
00844369038065ClearView 3SBL-3+13.0SBL-32023-01-25
00844369038072ClearView 3SBL-3+13.5SBL-32023-01-25
00844369038089ClearView 3SBL-3+14.0SBL-32023-01-25
00844369038102ClearView 3SBL-3+15.0SBL-32023-01-25
00844369038119ClearView 3SBL-3+15.25SBL-32023-01-25
00844369038126ClearView 3SBL-3+15.5SBL-32023-01-25
00844369038133ClearView 3SBL-3+15.75SBL-32023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05029867007026RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007033RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007040RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007057RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007064RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007071RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007088RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007095RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007101RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007118RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007125RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007132RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007149RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007156RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007163RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007170RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007187RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007194RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007200RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007217RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007224RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007231RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007248RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007255RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007262RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007279RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007286RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007293RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007309RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007316RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29