Reported Reactions

Devices › Unit, phacofragmentation

Device brand name · Unit phacofragmentation

Centurion Vision System Accessory Ozil Torsional Handpiece: medical device reports filed with FDA

651 reports name it, 2016–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HQC.

651
device reports naming the brand
0% of all MAUDE reports · about 63 a year
14
reports, 12 months to August 2026
98 in the 12 months before
77.1%
classified as malfunction
77.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 651 reports that name the brand "Centurion Vision System Accessory Ozil Torsional Handpiece" (unit phacofragmentation), received between March 2016 and July 2026; the manufacturer given most often on reports is Alcon Research - Irvine Technology Center. Spellings of one product vary from report to report.

14 reports arrived in the 12 months to August 2026, down 86% from 98 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 (77.1%) and injury (22.9%); 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 (29%), failure to deliver energy (19.8%) and energy output problem (9.1%). The patient problems coded most often are eye burn, appropriate clinical signs, symptoms and conditions term/code not available and corneal edema. 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

01122Sep 2021: 14Oct 2021: 15Nov 2021: 18Dec 2021: 102022Jan 2022: 5Feb 2022: 13Mar 2022: 11Apr 2022: 9May 2022: 6Jun 2022: 10Jul 2022: 16Aug 2022: 9Sep 2022: 7Oct 2022: 8Nov 2022: 11Dec 2022: 102023Jan 2023: 4Feb 2023: 4Mar 2023: 11Apr 2023: 10May 2023: 11Jun 2023: 6Jul 2023: 17Aug 2023: 10Sep 2023: 8Oct 2023: 14Nov 2023: 6Dec 2023: 72024Jan 2024: 22Feb 2024: 5Mar 2024: 8Apr 2024: 4May 2024: 15Jun 2024: 6Jul 2024: 8Aug 2024: 9Sep 2024: 16Oct 2024: 20Nov 2024: 10Dec 2024: 92025Jan 2025: 6Feb 2025: 11Mar 2025: 0Apr 2025: 8May 2025: 4Jun 2025: 5Jul 2025: 5Aug 2025: 4Sep 2025: 2Oct 2025: 1Nov 2025: 2Dec 2025: 12026Jan 2026: 0Feb 2026: 0Mar 2026: 2Apr 2026: 4May 2026: 1Jun 2026: 0Jul 2026: 1Aug 2026: 0

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

0781562016: 720162017: 32018: 820182019: 42020: 6120202021: 1562022: 11520222023: 1082024: 13220242025: 492026: 82026

Event type and report source

Event type, as classified on the report

Death0%0
Injury22.9%149
Malfunction77.1%502
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%651
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Overheating of device18929%1.8%
Failure to deliver energy12919.8%1.9%
Energy output problem599.1%1.7%
Excessive heating497.5%0.3%
Suction failure406.1%1.6%
Obstruction of flow243.7%0.6%
Suction problem233.5%4.2%
No flow172.6%0.6%
Inability to irrigate152.3%1.6%
Particulates152.3%2%
Therapeutic or diagnostic output failure142.2%0.6%
Decrease in suction132%1.8%
Improper flow or infusion91.4%1.2%
Material discolored91.4%0%
Complete blockage81.2%1.1%
Intermittent energy output81.2%0.1%
No device output81.2%0.9%
Power problem81.2%0.7%
Noise, audible40.6%0.7%
Defective devicethe device was defective30.5%0.7%

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)ReportsShare
Eye burn6710.3%
Appropriate clinical signs, symptoms and conditions term/code not available497.5%
Corneal edema243.7%
Toxic anterior segment syndrome (tass)243.7%
Endophthalmitisinfection inside the eye182.8%
Inflammationinflammation162.5%
Hypopyon152.3%
Corneal clouding/hazing132%
Blurred vision91.4%
Fluid discharge91.4%
Vitreous floatersfloaters in vision91.4%
Iritis81.2%
Uveitis71.1%
Conjunctivitispink eye60.9%
Eye paineye pain60.9%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureCenturion Vision System Accessory Ozil Torsional HandpieceProduct code HQCAll MAUDE reports
Reports65141,38126,136,888
Share of that pool—1.6%0%
Classified as death, per 1,000 reports009
Classified as injury22.9%21.9%36.2%
Classified as malfunction77.1%77.6%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
CONSTELLATION Vision System10,5305650%
Infiniti Vision System5,25900%
CENTURION Vision System3,7961430%
Infiniti Vision System Ozil3,53000%
Constellation With Laser1,37700.1%
Accurus 800cs1,45700%
Whitestar Signature System83900%
CENTURION Vision System (Active Sentry)7341450%
CENTURION Vision System, Accessory, Active Sentry Handpiece643790%
Laureate World Phaco System62480%
Stellaris Vision Enhancement System56530%
Accurus 400vs52500%
UNITY VCS Console3842980%
Stellaris Pc Vision Enhancement System36610%
Series 20000 Legacy37000%

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 Centurion Vision System Accessory Ozil Torsional Handpiece reports

How many FDA reports name Centurion Vision System Accessory Ozil Torsional Handpiece?

651 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.

What kinds of events are reported?

malfunction (77.1%) and injury (22.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overheating of device (29%), failure to deliver energy (19.8%), energy output problem (9.1%), excessive heating (7.5%) and suction failure (6.1%). 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 Centurion 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.