Oculus Innovative Sciences
Country not established
- Devices
- 16
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Oculus Innovative Sciences makes
Oculus Innovative Sciences manufactures topical wound care solutions, including antimicrobial gels (Microcyn Plus), anti-itch formulations (Alevicyn SG), and hydrogel-based treatments for scars and skin barriers (Ceramax, Microcyn Scar Management). The company also produces wound irrigation solutions (HydroCleanse) and endodontic irrigation for root canal procedures (Endocyn).
These products are regulated under FDA Class I and unclassified (U) devices, with most cleared via the 510(k) pathway. The company is based in the United States and its devices are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 6 recalls initiated by Oculus Innovative Sciences, the earliest on 2011-11-09 and the most recent on 2016-11-21. By recorded status: 6 terminated. The reasons filed fall into these groups: 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.
2016
- 21 Nov 2016 Z-0763-2017 Class II Terminated Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
2013
- 12 Feb 2013 Z-0890-2013 Class II Terminated Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.
2011
- 9 Nov 2011 Z-0448-2012 Unclassified (pre-2012) Terminated Unapproved drug claims and those not approved under 510K clearance.
- 9 Nov 2011 Z-0449-2012 Unclassified (pre-2012) Terminated Unapproved drug claims and those not approved under 510K clearance.
- 9 Nov 2011 Z-0450-2012 Unclassified (pre-2012) Terminated Unapproved drug claims and those not approved under 510K clearance.
- 9 Nov 2011 Z-0451-2012 Unclassified (pre-2012) Terminated Unapproved drug claims and those not approved under 510K clearance.
Frequently asked questions
How many devices does Oculus Innovative Sciences have in the registry?
The registry currently lists 16 devices for Oculus Innovative Sciences. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oculus Innovative Sciences's devices?
Among its 16 most recently registered devices, Oculus Innovative Sciences has devices listed in FDA 510(k) (16 devices).
What risk classes do Oculus Innovative Sciences's devices fall under?
Among its 16 most recently registered devices, the classes recorded for Oculus Innovative Sciences's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Oculus Innovative Sciences?
FDA recall records list 6 recalls initiated by Oculus Innovative Sciences, the most recent initiated on 21 Nov 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 Oculus Innovative Sciences in the registry?
The most recently registered devices listed for Oculus Innovative Sciences include LOYON, HYDROCLEANSE WOUND CARE SOLUTION, OCULUS MICROCYN WOUND GEL and Microcyn Plus Wound Care Solution.