DEVICE: Alcon AcrySof® (00380659909467)

Device Identifier (DI) Information

Alcon AcrySof®
Version 3
In Commercial Distribution

Alcon Laboratories, Inc.
00380659909467
GS1

1
008018525 *Terms of Use
AcrySof® IQ Toric IOL Calculator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Intraocular lens web-based calculator An application software designed to provide algorithms to assist a surgeon in performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected in order to optimize intraocular lens (IOL) model selection and axis placement within the capsular bag and/or to help the surgeon estimate the IOL optical power that will result in optimum correction of myopia. The software is accessed via an Internet connection utilizing a web browser (e.g., Microsoft? Internet Explorer). The applicable IOL labelling provides the URL address for the surgeon.
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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

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0d3a82fc-6ed1-4969-8950-0c87bab08972
March 29, 2018
2
December 13, 2016
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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)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+18008625266
web.masterus@alcon.com
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