DEVICE: SENSAR IOL (05050474514089)

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Device Identifier (DI) Information

SENSAR IOL
AR40E
AR40E00045
ABBOTT MEDICAL OPTICS INC.
05050474514089
GS1
1
ACRY 13.5MM 6OPT MOD C PMMA OPTIEDGE
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Device Characteristics

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

GMDN

[?]

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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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: less than 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 13.5 Millimeter
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Device Status

In Commercial Distribution
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)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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+1(877)266-4543
SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
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