DEVICE: TECNIS IOL (05050474605039)

Device Identifier (DI) Information

TECNIS IOL
ZXT150
In Commercial Distribution
ZXT150U115
JOHNSON & JOHNSON SURGICAL VISION, INC.
05050474605039
GS1

1
103021940 *Terms of Use
TECNIS SYMFONY TORIC ERV 11.5D CYL1.50
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35658 Posterior-chamber intraocular lens, pseudophakic
An 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
POE Extended depth of focus intraocular lens
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 13 Millimeter
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Device Record Status

258e8b02-21c1-4030-8399-11dcce7e540a
December 22, 2022
6
August 02, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

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