Device brand name · Implant eye valve
Ex-Press Glaucoma Filtration Device: medical device reports filed with FDA
666 reports name it, 2015–2026. Manufacturer given most often on reports: Optonol. Product code KYF.
- 666
- device reports naming the brand
- 0% of all MAUDE reports · about 58 a year
- 11
- reports, 12 months to August 2026
- 20 in the 12 months before
- 32.6%
- classified as malfunction
- 30.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
666 medical device reports received by FDA name the brand "Ex-Press Glaucoma Filtration Device" (implant eye valve); the manufacturer given most often on reports is Optonol; received from February 2015 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
11 reports arrived in the 12 months to August 2026, down 45% from 20 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 (67.4%) and malfunction (32.6%); 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 device operates differently than expected (14.4%), insufficient device problem information (9.3%) and complete blockage (6%). The patient problems coded most often are intraocular pressure increased, appropriate clinical signs, symptoms and conditions term/code not available 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 96 | 14.4% | 2.5% |
| Insufficient device problem information | 62 | 9.3% | 2.2% |
| Complete blockage | 40 | 6% | 9.2% |
| Malposition of device | 40 | 6% | 6.4% |
| No flow | 31 | 4.7% | 1.7% |
| Failure to eject | 23 | 3.5% | 0.6% |
| Obstruction of flow | 23 | 3.5% | 1.7% |
| Occlusion within devicethe device blocked | 14 | 2.1% | 0.8% |
| Migration or expulsion of device | 13 | 2% | 0.7% |
| Partial blockage | 13 | 2% | 1.3% |
| Failure to deliverthe device did not deliver the dose or item | 11 | 1.7% | 1.5% |
| Leak/splashthe device leaked | 10 | 1.5% | 0.3% |
| Positioning problem | 10 | 1.5% | 0.2% |
| Defective devicethe device was defective | 9 | 1.4% | 0.7% |
| Separation failure | 9 | 1.4% | 0.2% |
| Activation, positioning or separation problem | 8 | 1.2% | 0.7% |
| Device dislodged or dislocated | 8 | 1.2% | 1.8% |
| Filtration problem | 7 | 1.1% | 0.3% |
| Activation problem | 4 | 0.6% | 0.1% |
| Defective component | 4 | 0.6% | 0.3% |
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 | 142 | 21.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 23 | 3.5% |
| Eye injury | 23 | 3.5% |
| Visual impairmentreduced vision | 15 | 2.3% |
| Hyphema | 14 | 2.1% |
| Inflammationinflammation | 14 | 2.1% |
| Endophthalmitisinfection inside the eye | 13 | 2% |
| Intraocular pressure, delayed, uncontrolled | 13 | 2% |
| Corneal endothelial cell loss | 11 | 1.7% |
| Intraocular pressure decreased | 11 | 1.7% |
| Blurred vision | 10 | 1.5% |
| Fibrosis | 10 | 1.5% |
| Hemorrhage/blood loss/bleeding | 10 | 1.5% |
| Failure of implant | 9 | 1.4% |
| Glaucomaraised pressure in the eye | 9 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ex-Press Glaucoma Filtration Device | Product code KYF | All MAUDE reports |
|---|---|---|---|
| Reports | 666 | 4,403 | 26,136,888 |
| Share of that pool | — | 15.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 67.4% | 69.5% | 36.2% |
| Classified as malfunction | 32.6% | 30.3% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 Mini Glaucoma Shunt | 552 | 0 | 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 Glaucoma Filtration Device reports
How many FDA reports name Ex-Press Glaucoma Filtration Device?
666 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
injury (67.4%) and malfunction (32.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (14.4%), insufficient device problem information (9.3%), complete blockage (6%), malposition of device (6%) and no flow (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ex-Press Glaucoma Filtration Device 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.