Marietta Vision
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Marietta Vision makes
Marietta Vision manufactures tinted daily wear contact lenses designed for vision correction, utilizing a polymacon material for comfort and clarity.
The company’s products are regulated as Class II medical devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Marietta Vision, initiated on 2011-02-21. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 21 Feb 2011 Z-1557-2011 Unclassified (pre-2012) Terminated Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.
Frequently asked questions
How many devices does Marietta Vision have in the registry?
The registry currently lists 1 device for Marietta Vision. Devices recorded under merged duplicate company entries are counted once.
Which registries list Marietta Vision's devices?
Among its 1 most recently registered device, Marietta Vision has devices listed in FDA 510(k) (1 device).
What risk classes do Marietta Vision's devices fall under?
Among its 1 most recently registered device, the classes recorded for Marietta Vision's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Marietta Vision?
FDA recall records list 1 recall initiated by Marietta Vision, the most recent initiated on 21 Feb 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Marietta Vision in the registry?
The most recently registered devices listed for Marietta Vision include MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS.