Hoya Surgical Optics, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3006723646
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 2
What Hoya Surgical Optics, Inc. makes
Hoya Surgical Optics, Inc. manufactures ophthalmic injectors, including the HOYA Injector System, as well as pre-loaded intraocular lens (IOL) systems like PreVue and IPURE. These products are designed for cataract surgery and other refractive procedures, providing sterile, single-use delivery systems for IOLs and other ocular implants.
The company’s portfolio includes devices regulated under FDA Class I and Class III classifications, with some products authorised via the 510(k) pathway and others through the Premarket Approval (PMA) process. These devices are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Hoya Is Injector System Ref K081346
Regimes: 510(k) Registry: 510(k)- Regimes: PMA Registry: PMA
Company details
- FDA FEI number
- 3006723646
- Address
- 110 Progress Ave., Suite 175, Irvine, CA, 92618
FDA recalls
FDA recall records list 2 recalls initiated by HOYA SURGICAL OPTICS, INC., initiated on 2011-06-17. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 17 Jun 2011 Z-2801-2011 Unclassified (pre-2012) Terminated The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.
- 17 Jun 2011 Z-2802-2011 Unclassified (pre-2012) Terminated The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.
Frequently asked questions
How many devices does HOYA SURGICAL OPTICS, INC. have in the registry?
The registry currently lists 2 devices for HOYA SURGICAL OPTICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list HOYA SURGICAL OPTICS, INC.'s devices?
Among its 2 most recently registered devices, HOYA SURGICAL OPTICS, INC. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do HOYA SURGICAL OPTICS, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for HOYA SURGICAL OPTICS, INC.'s devices are Class I and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for HOYA SURGICAL OPTICS, INC.?
FDA recall records list 2 recalls initiated by HOYA SURGICAL OPTICS, INC., the most recent initiated on 17 Jun 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 HOYA SURGICAL OPTICS, INC. in the registry?
The most recently registered devices listed for HOYA SURGICAL OPTICS, INC. include HOYA IS INJECTOR SYSTEM and PreVue Pre-loaded System, IPURE Pre-loaded System.