DEVICE: Alcon Single-Piece PMMA (00380652540612)

Device Identifier (DI) Information

Alcon Single-Piece PMMA
TYPE01
In Commercial Distribution
TYPE01.120
Alcon Laboratories, Inc.
00380652540612
GS1

1
008018525 *Terms of Use
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
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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 [?]
P840060 000
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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 12
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Device Record Status

76ecfd0c-d5c2-4758-946d-2f6878d635f6
July 06, 2018
3
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

[?]
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

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