Devices › Unit, phacofragmentation
Device brand name · Phacofragmentation unit
Whitestar Signature System: medical device reports filed with FDA
839 reports name it, 2009–2022. Manufacturer given most often on reports: Abbott Medical Optics. Product code HQC.
- 839
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 66.9%
- 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 839 reports that name the brand "Whitestar Signature System" (phacofragmentation unit), received between June 2009 and October 2022; the manufacturer given most often on reports is Abbott Medical Optics. Spellings of one product vary from report to report.
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 (66.9%) and injury (32.9%); 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 device displays incorrect message (37.2%), device operates differently than expected (12.8%) and device inoperable (10%). The patient problems coded most often are no patient involvement, capsular bag tear and eye burn. 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 |
|---|---|---|---|
| Device displays incorrect message | 312 | 37.2% | 9% |
| Device operates differently than expectedthe device behaved unexpectedly | 107 | 12.8% | 6.7% |
| Device inoperablethe device could not be used | 84 | 10% | 3.7% |
| Device stops intermittentlythe device stopped now and then | 39 | 4.6% | 0.6% |
| Failure to cut | 37 | 4.4% | 9.2% |
| No display/image | 30 | 3.6% | 0.9% |
| Smoking | 25 | 3% | 0.2% |
| Suction problem | 21 | 2.5% | 4.2% |
| Failure to power up | 18 | 2.1% | 0.9% |
| Aspiration issue | 17 | 2% | 4.4% |
| Decrease in suction | 16 | 1.9% | 1.8% |
| Mechanical problema mechanical problem | 14 | 1.7% | 0.5% |
| Breakthe device broke | 11 | 1.3% | 1.3% |
| Loss of powerthe device lost power | 11 | 1.3% | 3.8% |
| Failure to prime | 9 | 1.1% | 0.7% |
| Reflux within device | 8 | 1% | 0.4% |
| Detachment of device or device componentpart of the device came off | 7 | 0.8% | 0.2% |
| Device emits odor | 7 | 0.8% | 0.2% |
| Display or visual feedback problem | 7 | 0.8% | 0.2% |
| Noise, audible | 6 | 0.7% | 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) | Reports | Share |
|---|---|---|
| No patient involvement | 313 | 37.3% |
| Capsular bag tear | 109 | 13% |
| Eye burn | 104 | 12.4% |
| Vitrectomy | 90 | 10.7% |
| Corneal edema | 22 | 2.6% |
| Surgical procedure, delayed | 21 | 2.5% |
| Visual impairmentreduced vision | 7 | 0.8% |
| Loss of vision | 3 | 0.4% |
| Swellingswelling | 3 | 0.4% |
| Vitreous loss | 3 | 0.4% |
| Discomfortdiscomfort | 2 | 0.2% |
| Endophthalmitisinfection inside the eye | 2 | 0.2% |
| Injurya physical injury | 2 | 0.2% |
| Not applicable | 2 | 0.2% |
| Awareness during anesthesia | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Whitestar Signature System | Product code HQC | All MAUDE reports |
|---|---|---|---|
| Reports | 839 | 41,381 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 32.9% | 21.9% | 36.2% |
| Classified as malfunction | 66.9% | 77.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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 Whitestar Signature System reports
How many FDA reports name Whitestar Signature System?
839 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 (66.9%) and injury (32.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (37.2%), device operates differently than expected (12.8%), device inoperable (10%), device stops intermittently (4.6%) and failure to cut (4.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Whitestar Signature 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.