DEVICE: TECNIS IOL (05050474558076)

Device Identifier (DI) Information

TECNIS IOL
PCB00
In Commercial Distribution
PCB0000105
ABBOTT MEDICAL OPTICS INC.
05050474558076
GS1

1
103021940 *Terms of Use
TECNIS ITEC PRELOADED 1PC MONO 10.5D
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
HQL 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

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Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 13 Millimeter
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Device Record Status

389c5c14-d146-4f2c-81d6-8038acd6584d
September 03, 2018
3
June 30, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

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