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FDA product code HQC · class 2 · Ophthalmic
Unit, phacofragmentation: medical device reports filed with FDA
41,381 reports carry this product code, 1992–2026; 30 brands with a page.
- 41,381
- reports with this product code
- 0.2% of all MAUDE reports
- 2,044
- reports, 12 months to August 2026
- 2,002 in the 12 months before
- 77.6%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code HQC is FDA's classification for "Unit, phacofragmentation" (ophthalmic panel), a class 2 device. 41,381 medical device reports carry this product code, 0.2% of the MAUDE database, from May 1992 to August 2026.
2,044 reports arrived in the 12 months to August 2026, close to the 2,002 of 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 (77.6%), injury (21.9%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Alcon Research - Irvine Technology Center | 19,888 | 48.1% |
| Alcon - Irvine Technology Center | 8,730 | 21.1% |
| Bausch + Lomb | 2,192 | 5.3% |
| Bausch & Lomb | 1,513 | 3.7% |
| Alcon - Irvine Technology Ctr | 1,408 | 3.4% |
| Abbott Medical Optics | 1,258 | 3% |
| Johnson & Johnson Surgical Vision | 961 | 2.3% |
| Storz Instrument | 503 | 1.2% |
| Alcon Research - Alcon Precision Device | 410 | 1% |
| Amo Manufacturing USA | 328 | 0.8% |
| Alcon Grieshaber | 239 | 0.6% |
| Alcon Laboratories | 192 | 0.5% |
| Bausch & Lomb Surgical | 144 | 0.3% |
| Allergan | 121 | 0.3% |
| Alcon Research - Houston | 71 | 0.2% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to cut | 3,811 | 9.2% |
| Device displays incorrect message | 3,736 | 9% |
| Device operates differently than expectedthe device behaved unexpectedly | 2,788 | 6.7% |
| Aspiration issue | 1,832 | 4.4% |
| Suction problem | 1,753 | 4.2% |
| Loss of powerthe device lost power | 1,564 | 3.8% |
| Device inoperablethe device could not be used | 1,533 | 3.7% |
| Device operational issue | 1,404 | 3.4% |
| Unexpected shutdown | 861 | 2.1% |
| Particulates | 833 | 2% |
| Operating system becomes nonfunctional | 807 | 2% |
| Failure to deliver energy | 782 | 1.9% |
| Overheating of device | 740 | 1.8% |
| Decrease in suction | 731 | 1.8% |
| Energy output problem | 705 | 1.7% |
| Suction failure | 662 | 1.6% |
| Inability to irrigate | 655 | 1.6% |
| Pressure problem | 604 | 1.5% |
| Insufficient device problem information | 589 | 1.4% |
| Occlusion within devicethe device blocked | 582 | 1.4% |
Questions about unit, phacofragmentation reports
What is product code HQC?
FDA's classification code for "Unit, phacofragmentation", class 2, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
41,381 reports through August 2026, 2,044 of them in the latest 12 months.
Which brands appear most often?
CONSTELLATION Vision System (10,528), Infiniti Vision System (5,205), CENTURION Vision System (3,796), Infiniti Vision System Ozil (3,527) and Constellation With Laser (1,376). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.