Innovative Ophthalmic Products, Inc. (Iop)
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Molteno3 Glaucoma Implant Ref K152996
Regimes: 510(k) Registry: 510(k)
FDA recalls
2016
- 22 Feb 2016 Z-1252-2016 Class II Terminated Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.
Frequently asked questions
How many devices does Innovative Ophthalmic Products, Inc. (Iop) have in the registry?
The registry currently lists 4 devices for Innovative Ophthalmic Products, Inc. (Iop). Devices recorded under merged duplicate company entries are counted once.
Which registries list Innovative Ophthalmic Products, Inc. (Iop)'s devices?
Among its 4 most recently registered devices, Innovative Ophthalmic Products, Inc. (Iop) has devices listed in FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Innovative Ophthalmic Products, Inc. (Iop)'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Innovative Ophthalmic Products, Inc. (Iop)'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Innovative Ophthalmic Products, Inc. (Iop)?
FDA recall records list 1 recall initiated by Innovative Ophthalmic Products, Inc. (Iop), the most recent initiated on 22 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 Innovative Ophthalmic Products, Inc. (Iop) in the registry?
The most recently registered devices listed for Innovative Ophthalmic Products, Inc. (Iop) include tarSys TS-121040, tarSys TS-81040, keraSys TK-41015 and Molteno3 Glaucoma Implant.