Devices › Intraocular pressure lowering implant
Device brand name · Intraocular pressure lowering implant
Cypass System: medical device reports filed with FDA
821 reports name it, 2017–2026. Manufacturer given most often on reports: Transcend Medical. Product code OGO.
- 821
- device reports naming the brand
- 0% of all MAUDE reports · about 86 a year
- 6
- reports, 12 months to August 2026
- 5 in the 12 months before
- 13%
- classified as malfunction
- 24.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
821 medical device reports received by FDA name the brand "Cypass System" (intraocular pressure lowering implant); the manufacturer given most often on reports is Transcend Medical; received from January 2017 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, up 20% from 5 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 (87%) and malfunction (13%); 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 insufficient device problem information (13.6%), patient-device incompatibility (5%) and malposition of device (4.6%). The patient problems coded most often are intraocular pressure increased, visual impairment and intraocular pressure, delayed, uncontrolled. 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 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 |
|---|---|---|---|
| Insufficient device problem information | 112 | 13.6% | 7.5% |
| Patient-device incompatibilitythe device did not suit the patient | 41 | 5% | 1.8% |
| Malposition of device | 38 | 4.6% | 15.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 32 | 3.9% | 1.4% |
| Migration or expulsion of device | 31 | 3.8% | 1.4% |
| Positioning problem | 19 | 2.3% | 1% |
| Device dislodged or dislocated | 11 | 1.3% | 3.3% |
| Improper or incorrect procedure or method | 8 | 1% | 1.1% |
| Therapeutic or diagnostic output failure | 8 | 1% | 0.3% |
| Obstruction of flow | 7 | 0.9% | 6.6% |
| Unexpected therapeutic results | 7 | 0.9% | 0.4% |
| Activation, positioning or separation problem | 6 | 0.7% | 0.4% |
| Complete blockage | 6 | 0.7% | 0.2% |
| Defective devicethe device was defective | 6 | 0.7% | 0.5% |
| Material protrusion/extrusion | 6 | 0.7% | 0.2% |
| Unintended movement | 5 | 0.6% | 0.2% |
| Difficult to insertthe device was hard to insert | 3 | 0.4% | 0.3% |
| Extrusion | 3 | 0.4% | 0.1% |
| Difficult or delayed positioning | 2 | 0.2% | 0.2% |
| Increase in pressure | 2 | 0.2% | 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 | 148 | 18% |
| Visual impairmentreduced vision | 66 | 8% |
| Intraocular pressure, delayed, uncontrolled | 46 | 5.6% |
| Hyphema | 42 | 5.1% |
| Hemorrhage/blood loss/bleeding | 41 | 5% |
| Painpain, site not specified | 37 | 4.5% |
| Blurred vision | 34 | 4.1% |
| Inflammationinflammation | 30 | 3.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 23 | 2.8% |
| Corneal decompensation | 23 | 2.8% |
| Corneal edema | 23 | 2.8% |
| Eye injury | 21 | 2.6% |
| Failure of implant | 20 | 2.4% |
| Loss of vision | 20 | 2.4% |
| Headachehead pain | 11 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cypass System | Product code OGO | All MAUDE reports |
|---|---|---|---|
| Reports | 821 | 2,684 | 26,136,888 |
| Share of that pool | — | 30.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 87% | 75.1% | 36.2% |
| Classified as malfunction | 13% | 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 |
|---|---|---|---|
| Istent Trabecular Micro-Bypass | 523 | 0 | 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 Cypass System reports
How many FDA reports name Cypass System?
821 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
injury (87%) and malfunction (13%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (13.6%), patient-device incompatibility (5%), malposition of device (4.6%), device operates differently than expected (3.9%) and migration or expulsion of device (3.8%). 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 Cypass System 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.