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
VICM5 13.2 (-12.5)
In Commercial Distribution
VICM5 13.2
STAAR SURGICAL COMPANY
VICM5 - Diopter: -12.5; Overall Diameter (Length): 13.2
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MTA | Lens, Intraocular, Phakic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P030016 | 035 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
756da75e-7bcd-4210-8b3f-2754e1775a9c
October 23, 2023
1
October 13, 2023
October 23, 2023
1
October 13, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined