Ocular Sciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ocular Sciences, Inc. makes
Ocular Sciences, Inc. manufactures soft contact lenses designed for daily wear, including UV-blocking and aspheric variants. Their products are made from hydrophilic materials such as Ocufilcon B and Ocufilcon F, intended for routine vision correction.
The company’s contact lenses are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are registered in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ocular Sciences, Inc., initiated on 2004-12-09. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 9 Dec 2004 Z-0348-05 Unclassified (pre-2012) Terminated Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
Frequently asked questions
How many devices does Ocular Sciences, Inc. have in the registry?
The registry currently lists 2 devices for Ocular Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ocular Sciences, Inc.'s devices?
Among its 2 most recently registered devices, Ocular Sciences, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ocular Sciences, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ocular Sciences, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ocular Sciences, Inc.?
FDA recall records list 1 recall initiated by Ocular Sciences, Inc., the most recent initiated on 9 Dec 2004. 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 Ocular Sciences, Inc. in the registry?
The most recently registered devices listed for Ocular Sciences, Inc. include BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS and HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS.