AccessGUDID - DEVICE: Visian Toric ICL (Implantable Collamer Lens for Myopia) (00841542104456)

GUDID

Device Identifier (DI) Information

Brand Name: Visian Toric ICL (Implantable Collamer Lens for Myopia)
Version or Model: TMICL 12.1(-8.0/4.0)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMICL12.1
Company Name: STAAR SURGICAL COMPANY

Primary DI Number: 00841542104456
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054751110 *Terms of Use

Device Description: Diopter: -8.0; Cylinder 4.0; Overall Diameter (Length): 12.1

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
QCB	Phakic Toric Intraocular Lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030016	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f128557f-f523-4b0b-81b4-c366057eddc1
Public Version Date: July 08, 2021
Public Version Number: 2
DI Record Publish Date: October 17, 2018