Devices › Unit, phacofragmentation
Device brand name · Unit phacofragmentation
INFINITI Vision System, Accessory, OZIL Torsional Handpiece: medical device reports filed with FDA
355 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HQC.
- 355
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 10
- reports, 12 months to August 2026
- 19 in the 12 months before
- 75.8%
- classified as malfunction
- 77.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
355 medical device reports received by FDA name the brand "INFINITI Vision System, Accessory, OZIL Torsional Handpiece" (unit phacofragmentation); the manufacturer given most often on reports is Alcon Research - Irvine Technology Center; received from April 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
10 reports arrived in the 12 months to August 2026, down 47% from 19 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 (75.8%) and injury (24.2%); 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 overheating of device (26.5%), failure to deliver energy (13.8%) and energy output problem (7.3%). The patient problems coded most often are eye burn, appropriate clinical signs, symptoms and conditions term/code not available and toxic anterior segment syndrome (tass). 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 |
|---|---|---|---|
| Overheating of device | 94 | 26.5% | 1.8% |
| Failure to deliver energy | 49 | 13.8% | 1.9% |
| Energy output problem | 26 | 7.3% | 1.7% |
| Suction problem | 18 | 5.1% | 4.2% |
| Suction failure | 14 | 3.9% | 1.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 2.8% | 6.7% |
| Obstruction of flow | 8 | 2.3% | 0.6% |
| Output problem | 8 | 2.3% | 0.6% |
| Occlusion within devicethe device blocked | 7 | 2% | 1.4% |
| Decrease in suction | 6 | 1.7% | 1.8% |
| Device displays incorrect message | 6 | 1.7% | 9% |
| Inability to irrigate | 6 | 1.7% | 1.6% |
| No device output | 6 | 1.7% | 0.9% |
| Complete blockage | 5 | 1.4% | 1.1% |
| Device inoperablethe device could not be used | 5 | 1.4% | 3.7% |
| Loss of powerthe device lost power | 5 | 1.4% | 3.8% |
| Therapeutic or diagnostic output failure | 5 | 1.4% | 0.6% |
| Contamination /decontamination problem | 4 | 1.1% | 0.1% |
| Defective devicethe device was defective | 4 | 1.1% | 0.7% |
| Intermittent energy output | 4 | 1.1% | 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 |
|---|---|---|
| Eye burn | 43 | 12.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 18 | 5.1% |
| Toxic anterior segment syndrome (tass) | 15 | 4.2% |
| Capsular bag tear | 9 | 2.5% |
| Endophthalmitisinfection inside the eye | 9 | 2.5% |
| Burn, thermal | 5 | 1.4% |
| Corneal edema | 5 | 1.4% |
| Fibrosis | 5 | 1.4% |
| Corneal clouding/hazing | 3 | 0.8% |
| Visual disturbances | 3 | 0.8% |
| Blurred vision | 2 | 0.6% |
| Burn(s)a burn | 2 | 0.6% |
| Conjunctivitispink eye | 2 | 0.6% |
| Drug resistant bacterial infection | 2 | 0.6% |
| Eye paineye pain | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | INFINITI Vision System, Accessory, OZIL Torsional Handpiece | Product code HQC | All MAUDE reports |
|---|---|---|---|
| Reports | 355 | 41,381 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 24.2% | 21.9% | 36.2% |
| Classified as malfunction | 75.8% | 77.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 |
|---|---|---|---|
| CONSTELLATION Vision System | 10,530 | 565 | 0% |
| 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% |
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 INFINITI Vision System, Accessory, OZIL Torsional Handpiece reports
How many FDA reports name INFINITI Vision System, Accessory, OZIL Torsional Handpiece?
355 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
malfunction (75.8%) and injury (24.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (26.5%), failure to deliver energy (13.8%), energy output problem (7.3%), suction problem (5.1%) and suction failure (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that INFINITI Vision System, Accessory, OZIL Torsional Handpiece 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.