Devices › Cannula, trocar, ophthalmic
Device brand name · Cannula trocar ophthalmic
EDGEPLUS Valved Entry System: medical device reports filed with FDA
229 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code NGY.
- 229
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 53
- reports, 12 months to August 2026
- 13 in the 12 months before
- 97.4%
- classified as malfunction
- 92.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
229 medical device reports received by FDA name the brand "EDGEPLUS Valved Entry System" (cannula trocar ophthalmic); the manufacturer given most often on reports is Alcon Research - Irvine Technology Center; received from June 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
53 reports arrived in the 12 months to August 2026, up 308% from 13 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 malfunction (97.4%) and injury (2.6%); across all cannula, trocar, ophthalmic reports (product code NGY) death is recorded in 0% and malfunction in 92.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (38%), dull, blunt (21%) and fluid/blood leak (13.5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, retinal hemorrhage and retinal tear. 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 361 reports carrying product code NGY. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 87 | 38% | 30.5% |
| Dull, blunt | 48 | 21% | 30.7% |
| Fluid/blood leak | 31 | 13.5% | 17.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.2% | 1.7% |
| Difficult to insertthe device was hard to insert | 3 | 1.3% | 1.4% |
| Detachment of device component | 2 | 0.9% | 2.5% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 1.1% |
| Physical resistance/sticking | 2 | 0.9% | 0.6% |
| Air leak | 1 | 0.4% | 0.3% |
| Component falling | 1 | 0.4% | 0.8% |
| Crackthe device cracked | 1 | 0.4% | 0.3% |
| Defective component | 1 | 0.4% | 0.3% |
| Detachment of device or device componentpart of the device came off | 1 | 0.4% | 1.1% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0.3% |
| Device dislodged or dislocated | 1 | 0.4% | 0.6% |
| Device inoperablethe device could not be used | 1 | 0.4% | 0.6% |
| Device slipped | 1 | 0.4% | 0.8% |
| Failure to adhere or bond | 1 | 0.4% | 0.3% |
| Fitting problem | 1 | 0.4% | 3% |
| Insufficient flow or under infusion | 1 | 0.4% | 0.6% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 2 | 0.9% |
| Retinal hemorrhage | 2 | 0.9% |
| Retinal tear | 2 | 0.9% |
| Injurya physical injury | 1 | 0.4% |
| Intraocular pressure decreased | 1 | 0.4% |
| Intraocular pressure increasedraised pressure in the eye | 1 | 0.4% |
| Intraocular pressure, delayed, uncontrolled | 1 | 0.4% |
| No patient involvement | 1 | 0.4% |
| Retinal detachmentthe retina separated from the back of the eye | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | EDGEPLUS Valved Entry System | Product code NGY | All MAUDE reports |
|---|---|---|---|
| Reports | 229 | 361 | 26,136,888 |
| Share of that pool | — | 63.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.6% | 6.4% | 36.2% |
| Classified as malfunction | 97.4% | 92.8% | 62.3% |
| Filed by the manufacturer | 100% | 96.7% | 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."
Questions about EDGEPLUS Valved Entry System reports
How many FDA reports name EDGEPLUS Valved Entry System?
229 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 53 in the latest 12 months.
What kinds of events are reported?
malfunction (97.4%) and injury (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (38%), dull, blunt (21%), fluid/blood leak (13.5%), device operates differently than expected (2.2%) and difficult to insert (1.3%). 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 EDGEPLUS Valved Entry 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.