FDA Device Intelligence
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Implant, Eye Valve

FDA product code KYF · Class 2 · Ophthalmic

30
Registered devices
4,300
Adverse events
6
Recalls
25
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-10-30Allergan PLCResidual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds
2016-02-22Innovative Ophthalmic Products, IncInnovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been
2006-04-12Eagle Vision IncProduct may have deformed valves which would cause the valve not to operate properly.
2006-04-12Eagle Vision IncProduct may have deformed valves which would cause the valve not to operate properly.
2006-04-12Eagle Vision IncProduct may have deformed valves which would cause the valve not to operate properly.
2006-04-12Eagle Vision IncProduct may have deformed valves which would cause the valve not to operate properly.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.