Device brand name · Aqueous shunt
Ex-Press Mini Glaucoma Shunt: medical device reports filed with FDA
552 reports name it, 2003–2015. Manufacturer given most often on reports: Optonol. Product code KYF.
- 552
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 37.3%
- classified as malfunction
- 30.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 552 reports that name the brand "Ex-Press Mini Glaucoma Shunt" (aqueous shunt), received between February 2003 and February 2015; the manufacturer given most often on reports is Optonol. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (62.1%), malfunction (37.3%) and other (0.5%); across all implant, eye valve reports (product code KYF) death is recorded in 0% and malfunction in 30.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are malposition of device (25%), complete blockage (17.9%) and failure to deliver (10.3%). The patient problems coded most often are intraocular pressure increased, intraocular pressure, delayed, uncontrolled and eye injury. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Ex-Press Mini Glaucoma Shunt was received in the five years to August 2026; the latest was received in February 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,403 reports carrying product code KYF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Malposition of device | 138 | 25% | 6.4% |
| Complete blockage | 99 | 17.9% | 9.2% |
| Failure to deliverthe device did not deliver the dose or item | 57 | 10.3% | 1.5% |
| No flow | 38 | 6.9% | 1.7% |
| Device dislodged or dislocated | 18 | 3.3% | 1.8% |
| Inaccurate delivery | 15 | 2.7% | 0.4% |
| Insufficient device problem information | 12 | 2.2% | 2.2% |
| Mechanical jam | 12 | 2.2% | 2.7% |
| Occlusion within devicethe device blocked | 11 | 2% | 0.8% |
| Obstruction of flow | 8 | 1.4% | 1.7% |
| Inadequate filtration process | 7 | 1.3% | 0.2% |
| Defective devicethe device was defective | 6 | 1.1% | 0.7% |
| Positioning failure | 6 | 1.1% | 0.5% |
| Filtration problem | 5 | 0.9% | 0.3% |
| Partial blockage | 5 | 0.9% | 1.3% |
| Bent | 3 | 0.5% | 0.1% |
| Excess flow or over-infusion | 3 | 0.5% | 0.1% |
| Component missing | 2 | 0.4% | 0.1% |
| Detachment of device or device componentpart of the device came off | 2 | 0.4% | 0.1% |
| Device disinfection or sterilization issue | 2 | 0.4% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Intraocular pressure increasedraised pressure in the eye | 123 | 22.3% |
| Intraocular pressure, delayed, uncontrolled | 52 | 9.4% |
| Eye injury | 30 | 5.4% |
| Hyphema | 16 | 2.9% |
| Visual impairmentreduced vision | 12 | 2.2% |
| Corneal edema | 9 | 1.6% |
| Hemorrhage/blood loss/bleeding | 8 | 1.4% |
| Inflammationinflammation | 7 | 1.3% |
| Painpain, site not specified | 7 | 1.3% |
| Low blood pressure/ hypotension | 6 | 1.1% |
| Endophthalmitisinfection inside the eye | 5 | 0.9% |
| Adhesion(s) | 4 | 0.7% |
| Erosion | 4 | 0.7% |
| Cataract, induced | 3 | 0.5% |
| Corneal decompensation | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ex-Press Mini Glaucoma Shunt | Product code KYF | All MAUDE reports |
|---|---|---|---|
| Reports | 552 | 4,403 | 26,136,888 |
| Share of that pool | — | 12.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 62.1% | 69.5% | 36.2% |
| Classified as malfunction | 37.3% | 30.3% | 62.3% |
| Filed by the manufacturer | 100% | 98.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code KYF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Xen 45 Gts | 1,663 | 88 | 0% |
| Ex-Press Glaucoma Filtration Device | 666 | 11 | 0% |
| Ahmed Glaucoma Valve | 374 | 29 | 0% |
| Baerveldt Shunt | 345 | 14 | 0% |
| Xen 45 Gts Australia | 207 | 0 | 0% |
| iStent Infinite Trabecular Micro-Bypass System | 180 | 65 | 0% |
| Istent Inject Trabecular Micro Bypass System | 217 | 0 | 0% |
| Istent Trabecular Micro-Bypass | 523 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Ex-Press Mini Glaucoma Shunt reports
How many FDA reports name Ex-Press Mini Glaucoma Shunt?
552 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (62.1%), malfunction (37.3%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malposition of device (25%), complete blockage (17.9%), failure to deliver (10.3%), no flow (6.9%) and device dislodged or dislocated (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ex-Press Mini Glaucoma Shunt was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.