FDA.report

TECNIS IOL

Primary DI
05050474602687
Brand
TECNIS IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
ZCT450
Catalog number
ZCT450U050
Device description
TECNIS TORIC 1-PIECE 6.0MM 05.0D CYL4.50
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MJPLENS, INTRAOCULAR, TORIC OPTICS

Product Code Classifications

CodeDeviceSpecialtyClass
MJPLens, Intraocular, Toric OpticsOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474602687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474602687050504746026875050474602687

GMDN Terms

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

TypeValueUnit
Outer Diameter13Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature045 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
103021940
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00380658544232Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544249Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544256Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544263Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544270Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544287Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544294Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544300Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544317Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544324Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544331Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544348Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544355Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544362Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544379Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544386Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544393Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544409Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544416Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544423Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544430Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544447Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544454Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544461Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544478Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544485Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544492Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544508Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544515Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544522Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23