FDA.reportPublic FDA data

TECNIS IOL

Primary DI
05050474536616
Brand
TECNIS IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
ZMA00
Catalog number
ZMA00U0105
Device description
TECNIS MF 3- PIECE 6.0MM 10.5 US
Published
2015-06-30
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
05050474536616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474536616050504745366165050474536616

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414846625313FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625320FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625337FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625344FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625351FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625368FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625375FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625382FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625399FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625405FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625412FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625429FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625436FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625443FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625450FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625467FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625474FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625481FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625498FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625504FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625511FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625528FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625535FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625542FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625559FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625566FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625573FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625580FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625597FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15
05414846625603FINEVISION HP Trifocal IOLPhysiolMFK2025-12-15