DEVICE: EVO/EVO+VISIAN Implantable Collamer Lens (00840311300983)

Device Identifier (DI) Information

EVO/EVO+VISIAN Implantable Collamer Lens
VICM5 13.2 (-12.5)
In Commercial Distribution
VICM5 13.2
STAAR SURGICAL COMPANY
00840311300983
GS1

1
054751110 *Terms of Use
VICM5 - Diopter: -12.5; Overall Diameter (Length): 13.2
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Device Characteristics

MR Safe
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47413 Posterior-chamber intraocular lens, phakic
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 provide refractive correction of vision, typically in the treatment of myopia or hyperopia, without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; it is also referred to as an implantable contact lens (ICL). 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
MTA Lens, Intraocular, Phakic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P030016 035
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 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

756da75e-7bcd-4210-8b3f-2754e1775a9c
October 23, 2023
1
October 13, 2023
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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

[?]
No Customer Contact currently defined
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