DEVICE: SENSAR IOL (05050474548459)

Device Identifier (DI) Information

SENSAR IOL
AAB00
In Commercial Distribution
AAB0000095
JOHNSON & JOHNSON SURGICAL VISION, INC.
05050474548459
GS1

1
103021940 *Terms of Use
SENSAR 1-PC CLEAR MONO 6.0MM 9.5D
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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
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

[?]
Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 13 Millimeter
Device Size Text, specify: OPTICAL POWER:9.50 DIO
Device Size Text, specify: OPTICAL ZONE DIAMETER:6.00 mm
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Device Record Status

030606f6-b07d-4ef9-8fe5-c43064422aae
October 20, 2023
7
March 10, 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
Yes
No CLOSE

Customer Contact

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