Catalog Number

VTICMO 13.7

Brand Name

EVO/EVO+VISIAN Implantable Collamer Lens

Version/Model Number

VTICMO 13.7 (-17.0/2.0)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P030016

Product Code

QCB

Product Code Name

Phakic Toric Intraocular Lens

Public Device Record Key

5196c262-6ec6-4510-8971-c0591fa05700

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-