Implant, Eye Valve
FDA adverse event reports and recall history for implant, eye valve (product code KYF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,367
- Deaths
- 0
- Injuries
- 3,041
- Malfunctions
- 1,317
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2006-05-06TerminatedOther
Krupin Eye Valve, P/N 6003
Product may have deformed valves which would cause the valve not to operate properly.
- 2006-05-06TerminatedOther
Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V
Product may have deformed valves which would cause the valve not to operate properly.
- 2006-05-06TerminatedOther
Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V
Product may have deformed valves which would cause the valve not to operate properly.
- 2006-05-06TerminatedOther
Valve-EV Glaucoma Ultra-Smooth, P/N 6006
Product may have deformed valves which would cause the valve not to operate properly.
- Open, ClassifiedVendor change control
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.
- TerminatedLabeling False and Misleading
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
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.
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