DEVICE: ACRYSOF® Monoflex® (00380652551458)

Device Identifier (DI) Information

ACRYSOF® Monoflex®
MA30AC
In Commercial Distribution
MA30AC.155
Alcon Laboratories, Inc.
00380652551458
GS1

1
008018525 *Terms of Use
AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 12.5mm LENGTH, 5.5mm ANTERIORASYMMETRIC BICONVEX OPTIC, Monoflex(TM*)5-DEGREE HAPTICS. *REG. U.S. PAT. & TM OFF.
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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

[?]
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diopter 15.5
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Device Record Status

8fc3e24f-a9d6-40ad-932e-5568f5cb537c
March 29, 2018
2
October 24, 2015
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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

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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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)862-5266
web.masterus@alcon.com
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