Devices › Intraocular pressure lowering implant
Device brand name · Intraocular pressure lowering implant
Istent Trabecular Micro-Bypass: medical device reports filed with FDA
523 reports name it, 2013–2020. Manufacturer given most often on reports: Glaukos. Product code OGO.
- 523
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 18.5%
- classified as malfunction
- 24.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
523 medical device reports received by FDA name the brand "Istent Trabecular Micro-Bypass" (intraocular pressure lowering implant); the manufacturer given most often on reports is Glaukos; received from April 2013 to December 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (81.5%) and malfunction (18.5%); across all intraocular pressure lowering implant reports (product code OGO) death is recorded in 0% and malfunction in 24.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are malposition of device (18.4%), obstruction of flow (12%) and insufficient device problem information (4.6%). The patient problems coded most often are intraocular pressure increased, hyphema 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 Istent Trabecular Micro-Bypass was received in the five years to August 2026; the latest was received in December 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,684 reports carrying product code OGO. 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 | 96 | 18.4% | 15.4% |
| Obstruction of flow | 63 | 12% | 6.6% |
| Insufficient device problem information | 24 | 4.6% | 7.5% |
| Device dislodged or dislocated | 22 | 4.2% | 3.3% |
| Improper or incorrect procedure or method | 12 | 2.3% | 1.1% |
| Difficult to position | 8 | 1.5% | 0.3% |
| Occlusion within devicethe device blocked | 7 | 1.3% | 0.3% |
| Positioning problem | 5 | 1% | 1% |
| Partial blockage | 4 | 0.8% | 0.1% |
| Component falling | 3 | 0.6% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.6% | 1.4% |
| Difficult or delayed positioning | 3 | 0.6% | 0.2% |
| Difficult to insertthe device was hard to insert | 3 | 0.6% | 0.3% |
| Entrapment of device | 3 | 0.6% | 0.1% |
| Migration or expulsion of device | 3 | 0.6% | 1.4% |
| Patient-device incompatibilitythe device did not suit the patient | 3 | 0.6% | 1.8% |
| Contamination /decontamination problem | 2 | 0.4% | 0% |
| Device or device fragments location unknown | 2 | 0.4% | 0.1% |
| Invalid sensing | 2 | 0.4% | 0.1% |
| Patient device interaction problem | 2 | 0.4% | 0.1% |
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 | 176 | 33.7% |
| Hyphema | 102 | 19.5% |
| Eye injury | 88 | 16.8% |
| Foreign body in patientpart of a device left in the patient | 69 | 13.2% |
| Loss of vision | 42 | 8% |
| Inflammationinflammation | 38 | 7.3% |
| Iritis | 31 | 5.9% |
| Intraocular pressure, delayed, uncontrolled | 24 | 4.6% |
| Visual impairmentreduced vision | 23 | 4.4% |
| Uveitis | 19 | 3.6% |
| Corneal edema | 12 | 2.3% |
| Therapeutic response, decreased | 9 | 1.7% |
| Macular edema | 8 | 1.5% |
| Blurred vision | 7 | 1.3% |
| Endophthalmitisinfection inside the eye | 7 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Istent Trabecular Micro-Bypass | Product code OGO | All MAUDE reports |
|---|---|---|---|
| Reports | 523 | 2,684 | 26,136,888 |
| Share of that pool | — | 19.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 81.5% | 75.1% | 36.2% |
| Classified as malfunction | 18.5% | 24.9% | 62.3% |
| Filed by the manufacturer | 100% | 97.9% | 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 OGO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cypass System | 821 | 6 | 0% |
| Hydrus Microstent | 476 | 115 | 0% |
| Istent Inject W Trabecular Micro Bypass System | 366 | 0 | 0% |
| Istent Inject Trabecular Micro Bypass System | 217 | 0 | 0% |
| iStent Infinite Trabecular Micro-Bypass System | 180 | 65 | 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 Istent Trabecular Micro-Bypass reports
How many FDA reports name Istent Trabecular Micro-Bypass?
523 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 (81.5%) and malfunction (18.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malposition of device (18.4%), obstruction of flow (12%), insufficient device problem information (4.6%), device dislodged or dislocated (4.2%) and improper or incorrect procedure or method (2.3%). 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 Istent Trabecular Micro-Bypass 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.