FDA.report

TECNIS IOL

Primary DI
05050474536982
Brand
TECNIS IOL
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
ZMA00
Catalog number
ZMA00U0290
Device description
TECNIS MF 3- PIECE 6.0MM 29.0 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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MFKLENS, MULTIFOCAL INTRAOCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474536982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474536982050504745369825050474536982

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

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05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
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05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
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