Devices › Instrument, vitreous aspiration and cutting, ac-powered
Device brand name · Instrument vitreous aspiration and cutting ac-powered
Laser Probes: medical device reports filed with FDA
512 reports name it, 2016–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HQE.
- 512
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 27
- reports, 12 months to August 2026
- 43 in the 12 months before
- 95.1%
- classified as malfunction
- 56.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
512 medical device reports received by FDA name the brand "Laser Probes" (instrument vitreous aspiration and cutting ac-powered); the manufacturer given most often on reports is Alcon Research - Irvine Technology Center; received from May 2016 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
27 reports arrived in the 12 months to August 2026, down 37% from 43 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 (95.1%) and injury (4.9%); 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 fitting problem (48.4%), difficult to insert (19.1%) and defective component (6.6%). The patient problems coded most often are no patient involvement, loss of vision and hemorrhage/blood loss/bleeding. 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 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 |
|---|---|---|---|
| Fitting problem | 248 | 48.4% | 4.4% |
| Difficult to insertthe device was hard to insert | 98 | 19.1% | 1.9% |
| Defective component | 34 | 6.6% | 1.3% |
| Failure to advance | 23 | 4.5% | 0.4% |
| Sticking | 21 | 4.1% | 1.2% |
| Physical resistance/sticking | 14 | 2.7% | 0.2% |
| Material deformation | 7 | 1.4% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.2% | 0.5% |
| Energy output problem | 6 | 1.2% | 0.1% |
| Material integrity problema problem with the device material | 6 | 1.2% | 0.1% |
| Mechanical problema mechanical problem | 6 | 1.2% | 0.3% |
| Entrapment of device | 5 | 1% | 0.2% |
| Inadequacy of device shape and/or size | 5 | 1% | 0.2% |
| Device dislodged or dislocated | 4 | 0.8% | 0.1% |
| Difficult to removethe device was hard to remove | 3 | 0.6% | 0.5% |
| Display or visual feedback problem | 3 | 0.6% | 0.1% |
| Material twisted/bent | 3 | 0.6% | 0.1% |
| Component incompatible | 2 | 0.4% | 0% |
| Failure to fire | 2 | 0.4% | 0% |
| Noise, audible | 2 | 0.4% | 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 |
|---|---|---|
| No patient involvement | 7 | 1.4% |
| Loss of vision | 5 | 1% |
| Hemorrhage/blood loss/bleeding | 4 | 0.8% |
| Blurred vision | 3 | 0.6% |
| Eye infections | 3 | 0.6% |
| Intraocular pressure increasedraised pressure in the eye | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Endophthalmitisinfection inside the eye | 2 | 0.4% |
| Inflammationinflammation | 2 | 0.4% |
| Retinal detachmentthe retina separated from the back of the eye | 2 | 0.4% |
| Retinal injury | 2 | 0.4% |
| Retinal tear | 2 | 0.4% |
| Cataractclouding of the eye lens | 1 | 0.2% |
| Eye burn | 1 | 0.2% |
| Eye paineye pain | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Laser Probes | Product code HQE | All MAUDE reports |
|---|---|---|---|
| Reports | 512 | 5,964 | 26,136,888 |
| Share of that pool | — | 8.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 4.9% | 42.3% | 36.2% |
| Classified as malfunction | 95.1% | 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% |
| 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 600ds | 217 | 0 | 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 Laser Probes reports
How many FDA reports name Laser Probes?
512 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 27 in the latest 12 months.
What kinds of events are reported?
malfunction (95.1%) and injury (4.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fitting problem (48.4%), difficult to insert (19.1%), defective component (6.6%), failure to advance (4.5%) and sticking (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 Laser Probes 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.