Devices › Unit, phacofragmentation
Device brand name · Unit phacofragmentation
CONSTELLATION Vision System: medical device reports filed with FDA
10,530 reports name it, 2010–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HQC.
- 10,530
- device reports naming the brand
- 0% of all MAUDE reports · about 642 a year
- 565
- reports, 12 months to August 2026
- 679 in the 12 months before
- 91.7%
- classified as malfunction
- 77.6% across the product code
- 0%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 10,530 reports that name the brand "CONSTELLATION Vision System" (unit phacofragmentation), received between February 2010 and August 2026; the manufacturer given most often on reports is Alcon Research - Irvine Technology Center. Spellings of one product vary from report to report.
565 reports arrived in the 12 months to August 2026, down 17% from 679 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 (91.7%) and injury (8.3%); across all unit, phacofragmentation reports (product code HQC) death is recorded in 0% and malfunction in 77.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to cut (14%), device operates differently than expected (10.1%) and device displays incorrect message (7.3%). The patient problems coded most often are no patient involvement, intraocular pressure, delayed, uncontrolled and appropriate clinical signs, symptoms and conditions term/code not available. 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 41,381 reports carrying product code HQC. 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 |
|---|---|---|---|
| Failure to cut | 1,471 | 14% | 9.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,062 | 10.1% | 6.7% |
| Device displays incorrect message | 772 | 7.3% | 9% |
| Device inoperablethe device could not be used | 514 | 4.9% | 3.7% |
| Energy output problem | 345 | 3.3% | 1.7% |
| Device operational issue | 319 | 3% | 3.4% |
| Air leak | 315 | 3% | 1.1% |
| Pressure problem | 311 | 3% | 1.5% |
| Suction problem | 310 | 2.9% | 4.2% |
| Aspiration issue | 294 | 2.8% | 4.4% |
| Infusion or flow problema problem with flow or infusion | 273 | 2.6% | 1.3% |
| Operating system becomes nonfunctional | 271 | 2.6% | 2% |
| Loss of powerthe device lost power | 267 | 2.5% | 3.8% |
| Leak/splashthe device leaked | 238 | 2.3% | 0.8% |
| Fluid/blood leak | 227 | 2.2% | 1.2% |
| Unexpected shutdown | 206 | 2% | 2.1% |
| Decrease in suction | 189 | 1.8% | 1.8% |
| Failure to deliver energy | 181 | 1.7% | 1.9% |
| Suction failure | 181 | 1.7% | 1.6% |
| Output problem | 166 | 1.6% | 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 |
|---|---|---|
| No patient involvement | 490 | 4.7% |
| Intraocular pressure, delayed, uncontrolled | 129 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 111 | 1.1% |
| Intraocular pressure decreased | 78 | 0.7% |
| Endophthalmitisinfection inside the eye | 75 | 0.7% |
| Retinal detachmentthe retina separated from the back of the eye | 67 | 0.6% |
| Eye burn | 66 | 0.6% |
| Hemorrhage/blood loss/bleeding | 59 | 0.6% |
| Capsular bag tear | 52 | 0.5% |
| Retinal tear | 44 | 0.4% |
| Intraocular pressure increasedraised pressure in the eye | 42 | 0.4% |
| Eye injury | 31 | 0.3% |
| Loss of vision | 30 | 0.3% |
| Collapse | 27 | 0.3% |
| Corneal edema | 27 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CONSTELLATION Vision System | Product code HQC | All MAUDE reports |
|---|---|---|---|
| Reports | 10,530 | 41,381 | 26,136,888 |
| Share of that pool | — | 25.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 8.3% | 21.9% | 36.2% |
| Classified as malfunction | 91.7% | 77.6% | 62.3% |
| Filed by the manufacturer | 99.8% | 98.4% | 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 HQC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Infiniti Vision System | 5,259 | 0 | 0% |
| CENTURION Vision System | 3,796 | 143 | 0% |
| Infiniti Vision System Ozil | 3,530 | 0 | 0% |
| Constellation With Laser | 1,377 | 0 | 0.1% |
| Accurus 800cs | 1,457 | 0 | 0% |
| Whitestar Signature System | 839 | 0 | 0% |
| CENTURION Vision System (Active Sentry) | 734 | 145 | 0% |
| Centurion Vision System Accessory Ozil Torsional Handpiece | 651 | 14 | 0% |
| CENTURION Vision System, Accessory, Active Sentry Handpiece | 643 | 79 | 0% |
| Laureate World Phaco System | 624 | 8 | 0% |
| Stellaris Vision Enhancement System | 565 | 3 | 0% |
| Accurus 400vs | 525 | 0 | 0% |
| UNITY VCS Console | 384 | 298 | 0% |
| Stellaris Pc Vision Enhancement System | 366 | 1 | 0% |
| Series 20000 Legacy | 370 | 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 CONSTELLATION Vision System reports
How many FDA reports name CONSTELLATION Vision System?
10,530 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 565 in the latest 12 months.
What kinds of events are reported?
malfunction (91.7%) and injury (8.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to cut (14%), device operates differently than expected (10.1%), device displays incorrect message (7.3%), device inoperable (4.9%) and energy output problem (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CONSTELLATION Vision 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.