FDA.reportPublic FDA data

TECNIS IOL

Primary DI
05050474688810
Brand
TECNIS IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
ZKU375
Catalog number
ZKU375U215
Device description
TECNIS TORIC LOW ADD 1-PC 21.5D CYL3.75
Published
2020-04-23
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05050474688810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474688810050504746888105050474688810

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature045 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
103021940
Device count
1
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
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00844369038010ClearView 3Lenstec Barbados IncMFK2023-01-25
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00844369038041ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038058ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038065ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038072ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038089ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038096ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038102ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038119ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038126ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038133ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038140ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038157ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038164ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038171ClearView 3Lenstec Barbados IncMFK2023-01-25
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00844369038218ClearView 3Lenstec Barbados IncMFK2023-01-25
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00844369038232ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038249ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038256ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038263ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038270ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038287ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038294ClearView 3Lenstec Barbados IncMFK2023-01-25