Devices › Instrument, vitreous aspiration and cutting, ac-powered
Device brand name · Ophthalmic surgery system
Accurus 600ds: medical device reports filed with FDA
217 reports name it, 1998–2014. Manufacturer given most often on reports: Alcon - Irvine Technology Center. Product code HQE.
- 217
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 61.3%
- classified as malfunction
- 56.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 217 reports that name the brand "Accurus 600ds" (ophthalmic surgery system), received between June 1998 and December 2014; the manufacturer given most often on reports is Alcon - Irvine Technology Center. 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 (61.3%) and injury (38.7%); across all instrument, vitreous aspiration and cutting, ac-powered reports (product code HQE) death is recorded in 0% and malfunction in 56.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (11.1%), device displays incorrect message (10.1%) and failure to cut (5.5%). The patient problems coded most often are membrane, breakage of, eye burn and surgical procedure, additional. 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 Accurus 600ds was received in the five years to August 2026; the latest was received in December 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,964 reports carrying product code HQE. 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 |
|---|---|---|---|
| Replace | 24 | 11.1% | 9.7% |
| Device displays incorrect message | 22 | 10.1% | 4% |
| Failure to cut | 12 | 5.5% | 7.6% |
| Other (for use when an appropriate device code cannot be identified) | 10 | 4.6% | 4.5% |
| Thermal decomposition of device | 9 | 4.1% | 9.4% |
| Device inoperablethe device could not be used | 8 | 3.7% | 2.2% |
| Sticking | 8 | 3.7% | 1.2% |
| Design/structure problem | 7 | 3.2% | 0.1% |
| Aspiration issue | 5 | 2.3% | 0.1% |
| Device issuea problem with the device | 5 | 2.3% | 10.2% |
| Device remains activated | 5 | 2.3% | 0.3% |
| Inability to irrigate | 5 | 2.3% | 1.5% |
| Performance | 5 | 2.3% | 0.1% |
| Aspiration, incomplete | 4 | 1.8% | 1.9% |
| Loss of powerthe device lost power | 4 | 1.8% | 2.4% |
| Material fragmentation | 4 | 1.8% | 0.4% |
| Defective component | 3 | 1.4% | 1.3% |
| Fitting problem | 3 | 1.4% | 4.4% |
| Fluid/blood leak | 3 | 1.4% | 0.3% |
| Hole in material | 3 | 1.4% | 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) | Reports | Share |
|---|---|---|
| Membrane, breakage of | 26 | 12% |
| Eye burn | 24 | 11.1% |
| Surgical procedure, additional | 19 | 8.8% |
| Other (for use when an appropriate patient code cannot be identified) | 18 | 8.3% |
| Surgery, prolonged | 15 | 6.9% |
| Therapy/non-surgical treatment, additional | 9 | 4.1% |
| Endophthalmitisinfection inside the eye | 6 | 2.8% |
| Eye injury | 6 | 2.8% |
| Surgical procedure | 6 | 2.8% |
| Surgical procedure aborted/stopped | 6 | 2.8% |
| Collapse | 5 | 2.3% |
| Retinal injury | 5 | 2.3% |
| Visual impairmentreduced vision | 5 | 2.3% |
| Retinal detachmentthe retina separated from the back of the eye | 4 | 1.8% |
| Burn(s)a burn | 3 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accurus 600ds | Product code HQE | All MAUDE reports |
|---|---|---|---|
| Reports | 217 | 5,964 | 26,136,888 |
| Share of that pool | — | 3.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 38.7% | 42.3% | 36.2% |
| Classified as malfunction | 61.3% | 56.3% | 62.3% |
| Filed by the manufacturer | 100% | 95.2% | 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 HQE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Series Twenty Thousand Legacy | 2,573 | 0 | 0% |
| Laser Probes | 512 | 27 | 0% |
| Storz Premiere Ophthalmic Microsurgical Unit | 370 | 0 | 0% |
| HyperVit Vitrectomy Probe | 336 | 221 | 0% |
| Accurus 800cs | 1,457 | 0 | 0% |
| Backflush Handle DSP | 233 | 43 | 0% |
| Accurus 400vs | 525 | 0 | 0% |
| Infiniti Vision System | 5,259 | 0 | 0% |
| Alcon | 180 | 2 | 0% |
| Millennium Microsurgical System | 152 | 0 | 0% |
| Series 20000 Legacy | 370 | 0 | 0% |
| Viscoat | 220 | 0 | 0.5% |
| Infiniti Vision System Ozil | 3,530 | 0 | 0% |
| M Series | 27,112 | 4 | 2.3% |
| Custom Pak | 1,262 | 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 Accurus 600ds reports
How many FDA reports name Accurus 600ds?
217 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 (61.3%) and injury (38.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (11.1%), device displays incorrect message (10.1%), failure to cut (5.5%), other (for use when an appropriate device code cannot be identified) (4.6%) and thermal decomposition of device (4.1%). 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 Accurus 600ds 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.