Catalog Number

TMICL13.7

Brand Name

Visian Toric ICL (Implantable Collamer Lens for Myopia)

Version/Model Number

TMICL 13.7 (-16.0/3.0)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

e48da87f-1572-4889-9a35-2e2009986d05

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

October 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-