Reported Reactions

Devices › Unit, phacofragmentation

Device brand name · Stellaris anterior system

Micro Incision Vacuum Pack: medical device reports filed with FDA

165 reports name it, 2011–2015. Manufacturer given most often on reports: Bausch & Lomb. Product code HQC.

165
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
87.9%
classified as malfunction
77.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

165 medical device reports received by FDA name the brand "Micro Incision Vacuum Pack" (stellaris anterior system); the manufacturer given most often on reports is Bausch & Lomb; received from May 2011 to July 2015. 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 (87.9%) and injury (12.1%); 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 difficult to insert (52.1%), complete blockage (23.6%) and aspiration issue (8.5%). The patient problems coded most often are eye injury, capsular bag tear and foreign body in patient. 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 Micro Incision Vacuum Pack was received in the five years to August 2026; the latest was received in July 2015.

By year received

031622011: 3220112012: 4120122013: 6220132014: 1720142015: 132015

Event type and report source

Event type, as classified on the report

Death0%0
Injury12.1%20
Malfunction87.9%145
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%165
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
Difficult to insertthe device was hard to insert8652.1%1.1%
Complete blockage3923.6%1.1%
Aspiration issue148.5%4.4%
Insufficient device problem information116.7%1.4%
Device issuea problem with the device74.2%0.9%
Occlusion within devicethe device blocked53%1.4%
Particulates42.4%2%
Fitting problem31.8%0.4%
Manufacturing, packaging or shipping problem31.8%0%
Structural problem31.8%0%
Failure to advance10.6%0%
Human-device interface problem10.6%0%
Improper flow or infusion10.6%1.2%
Infusion or flow problema problem with flow or infusion10.6%1.3%
Material integrity problema problem with the device material10.6%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)ReportsShare
Eye injury159.1%
Capsular bag tear31.8%
Foreign body in patientpart of a device left in the patient31.8%
Achalasia10.6%
Cataract, induced10.6%
Corneal edema10.6%
Edemaswelling from fluid10.6%
Loss of vision10.6%

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

In context

MeasureMicro Incision Vacuum PackProduct code HQCAll MAUDE reports
Reports16541,38126,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports009
Classified as injury12.1%21.9%36.2%
Classified as malfunction87.9%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 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 Micro Incision Vacuum Pack reports

How many FDA reports name Micro Incision Vacuum Pack?

165 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 (87.9%) and injury (12.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

difficult to insert (52.1%), complete blockage (23.6%), aspiration issue (8.5%), insufficient device problem information (6.7%) and device issue (4.2%). 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 Micro Incision Vacuum Pack 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.