Device brand name · Implant eye valve
Xen 45 Gts: medical device reports filed with FDA
1,663 reports name it, 2016–2026. Manufacturer given most often on reports: Allergan Irvine. Product code KYF.
- 1,663
- device reports naming the brand
- 0% of all MAUDE reports · about 174 a year
- 88
- reports, 12 months to August 2026
- 141 in the 12 months before
- 35.8%
- 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 1,663 reports that name the brand "Xen 45 Gts" (implant eye valve), received between December 2016 and August 2026; the manufacturer given most often on reports is Allergan Irvine. Spellings of one product vary from report to report.
88 reports arrived in the 12 months to August 2026, down 38% from 141 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 (64.2%) and malfunction (35.8%); 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 physical resistance/sticking (19.9%), complete blockage (7.9%) and migration (7.5%). The patient problems coded most often are intraocular pressure increased, eye injury and erosion. 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 |
|---|---|---|---|
| Physical resistance/sticking | 331 | 19.9% | 7.8% |
| Complete blockage | 132 | 7.9% | 9.2% |
| Migrationthe device moved from where it was placed | 124 | 7.5% | 3.4% |
| Mechanical jam | 105 | 6.3% | 2.7% |
| Device appears to trigger rejection | 92 | 5.5% | 2.5% |
| Fracturea broken bone | 85 | 5.1% | 2.3% |
| Malposition of device | 54 | 3.2% | 6.4% |
| Material twisted/bent | 38 | 2.3% | 1.2% |
| Retraction problem | 36 | 2.2% | 0.7% |
| Breakthe device broke | 30 | 1.8% | 2.1% |
| Partial blockage | 24 | 1.4% | 1.3% |
| Activation, positioning or separation problem | 20 | 1.2% | 0.7% |
| Improper or incorrect procedure or method | 18 | 1.1% | 0.6% |
| Off-label use | 17 | 1% | 0.6% |
| Expiration date error | 15 | 0.9% | 0.3% |
| Migration or expulsion of device | 15 | 0.9% | 0.7% |
| Device markings/labelling problema problem with the device markings or label | 14 | 0.8% | 0.3% |
| Dull, blunt | 12 | 0.7% | 0.2% |
| Positioning failure | 11 | 0.7% | 0.5% |
| Insufficient device problem information | 10 | 0.6% | 2.2% |
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 | 382 | 23% |
| Eye injury | 307 | 18.5% |
| Erosion | 209 | 12.6% |
| Endophthalmitisinfection inside the eye | 129 | 7.8% |
| Fibrosis | 99 | 6% |
| Loss of vision | 99 | 6% |
| Hemorrhage/blood loss/bleeding | 55 | 3.3% |
| Glaucomaraised pressure in the eye | 49 | 2.9% |
| Failure of implant | 46 | 2.8% |
| Therapeutic response, decreased | 32 | 1.9% |
| Visual impairmentreduced vision | 30 | 1.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 27 | 1.6% |
| Fluid discharge | 27 | 1.6% |
| Hyphema | 27 | 1.6% |
| No patient involvement | 25 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Xen 45 Gts | Product code KYF | All MAUDE reports |
|---|---|---|---|
| Reports | 1,663 | 4,403 | 26,136,888 |
| Share of that pool | — | 37.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 64.2% | 69.5% | 36.2% |
| Classified as malfunction | 35.8% | 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 |
|---|---|---|---|
| Ex-Press Glaucoma Filtration Device | 666 | 11 | 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 Xen 45 Gts reports
How many FDA reports name Xen 45 Gts?
1,663 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 88 in the latest 12 months.
What kinds of events are reported?
injury (64.2%) and malfunction (35.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (19.9%), complete blockage (7.9%), migration (7.5%), mechanical jam (6.3%) and device appears to trigger rejection (5.5%). 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 Xen 45 Gts 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.