Reported Reactions

Devices › Unit, phacofragmentation

Device brand name · Ophthalmic microsurgical unit

Millennium Microsurgical System: medical device reports filed with FDA

152 reports name it, 1998–2021. Manufacturer given most often on reports: Bausch & Lomb Surgical. Product code HQC.

152
device reports naming the brand
0% of all MAUDE reports · about 5 a year
0
reports, 12 months to August 2026
0 in the 12 months before
53.3%
classified as malfunction
77.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

152 medical device reports received by FDA name the brand "Millennium Microsurgical System" (ophthalmic microsurgical unit); the manufacturer given most often on reports is Bausch & Lomb Surgical; received from March 1998 to June 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (53.3%) and injury (46.7%); 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 device issue (35.5%), replace (33.6%) and failure, intermittent (8.6%). The patient problems coded most often are eye injury, membrane, breakage of and surgery, prolonged. 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

No report naming Millennium Microsurgical System was received in the five years to August 2026; the latest was received in June 2021.

By year received

036711998: 7119981999: 142000: 1120002001: 82003: 720032004: 62005: 520052006: 62007: 1120072008: 52010: 520102021: 3

Event type and report source

Event type, as classified on the report

Death0%0
Injury46.7%71
Malfunction53.3%81
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.3%151
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.7%1

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
Device issuea problem with the device5435.5%0.9%
Replace5133.6%0.3%
Failure, intermittent138.6%0.1%
Malfunction117.2%0.2%
Aspiration, excessive85.3%0%
Aspiration, incomplete63.9%0.2%
Defective component63.9%0.5%
Other (for use when an appropriate device code cannot be identified)53.3%0.6%
Self-activation or keying53.3%0.4%
Computer hardware error42.6%0%
Suction problem42.6%4.2%
Inability to irrigate32%1.6%
Power conditioning problem32%0.1%
Unit inactivated32%0%
Blank screen21.3%0%
Device remains activated21.3%0%
Fitting problem21.3%0.4%
System fails to activate21.3%0%
Computer failure10.7%0%
Detachment of device component10.7%0.2%

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 injury138.6%
Membrane, breakage of85.3%
Surgery, prolonged74.6%
Surgical procedure, additional63.9%
Surgical procedure32%
Burn(s)a burn10.7%
Collapse10.7%
Eye burn10.7%
Improved patient condition10.7%
Rupturethe device burst10.7%
Surgical procedure aborted/stopped10.7%
Surgical procedure, delayed10.7%

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

In context

MeasureMillennium Microsurgical SystemProduct code HQCAll MAUDE reports
Reports15241,38126,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports009
Classified as injury46.7%21.9%36.2%
Classified as malfunction53.3%77.6%62.3%
Filed by the manufacturer99.3%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 Ozil Torsional Handpiece651140%
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%

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 Millennium Microsurgical System reports

How many FDA reports name Millennium Microsurgical System?

152 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (53.3%) and injury (46.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device issue (35.5%), replace (33.6%), failure, intermittent (8.6%), malfunction (7.2%) and aspiration, excessive (5.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Millennium Microsurgical 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.