Acu Focus, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Acu Focus, Inc. makes
Acu Focus, Inc. manufactures the IC-8 Apthera Intraocular Lens (IOL), a device implanted during cataract surgery to restore vision by replacing the eye’s natural lens.
The IC-8 Apthera IOL is classified as a Class III medical device in the US and is listed under the FDA’s Premarket Approval (PMA) pathway. The company is based in the United States.
Catalogue
IC-8 Apthera Intraocular Lens (IOL) Ref P210005
Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 1 recall initiated by Acu Focus, Inc., initiated on 2016-02-11. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 11 Feb 2016 Z-1235-2016 Class II Terminated AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Frequently asked questions
How many devices does Acu Focus, Inc. have in the registry?
The registry currently lists 1 device for Acu Focus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acu Focus, Inc.'s devices?
Among its 1 most recently registered device, Acu Focus, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Acu Focus, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Acu Focus, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Acu Focus, Inc.?
FDA recall records list 1 recall initiated by Acu Focus, Inc., the most recent initiated on 11 Feb 2016. 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 Acu Focus, Inc. in the registry?
The most recently registered devices listed for Acu Focus, Inc. include IC-8 Apthera Intraocular Lens (IOL).