FDA.reportPublic FDA data

TECNIS ODYSSEY TORIC II IOL

Primary DI
05050474811096
Brand
TECNIS ODYSSEY TORIC II IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
DRT150
Catalog number
DRT1500070
Device description
TEC ODYSSEY TOR II SMPCY 07.0D CYL1.50
Published
2024-01-19
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05050474811096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474811096050504748110965050474811096

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
Device Size Text, specify0
Outer Diameter13Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature5 Degrees Celsius35 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

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