Devices › Microscope, operating & accessories, ac-powered, ophthalmic
Device brand name · Microscope operating & acc ac-powered ophthalmic
LuxOR Ophthalmic Microscopes: medical device reports filed with FDA
289 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Irvine Technology Center. Product code HRM.
- 289
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 45
- reports, 12 months to August 2026
- 49 in the 12 months before
- 91%
- classified as malfunction
- 80.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 289 reports that name the brand "LuxOR Ophthalmic Microscopes" (microscope operating & acc ac-powered ophthalmic), received between March 2015 and August 2026; the manufacturer given most often on reports is Alcon Research - Irvine Technology Center. Spellings of one product vary from report to report.
45 reports arrived in the 12 months to August 2026, close to the 49 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 (91%) and injury (9%); across all microscope, operating & accessories, ac-powered, ophthalmic reports (product code HRM) death is recorded in 0% and malfunction in 80.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are loose or intermittent connection (39.8%), unintended movement (32.9%) and break (3.5%). The patient problems coded most often are no patient involvement, capsular bag tear and appropriate clinical signs, symptoms and conditions term/code not available. 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 370 reports carrying product code HRM. 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 |
|---|---|---|---|
| Loose or intermittent connection | 115 | 39.8% | 31.6% |
| Unintended movement | 95 | 32.9% | 26.8% |
| Breakthe device broke | 10 | 3.5% | 3.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 2.8% | 3.8% |
| Device slipped | 8 | 2.8% | 2.2% |
| Component falling | 6 | 2.1% | 4.3% |
| Defective component | 6 | 2.1% | 1.6% |
| Device displays incorrect message | 6 | 2.1% | 1.9% |
| Misfocusing | 6 | 2.1% | 1.6% |
| Unstable | 5 | 1.7% | 1.4% |
| Mechanics altered | 4 | 1.4% | 1.4% |
| Optical problem | 4 | 1.4% | 2.2% |
| Component missing | 3 | 1% | 0.8% |
| Detachment of device or device componentpart of the device came off | 3 | 1% | 1.6% |
| Device inoperablethe device could not be used | 3 | 1% | 1.1% |
| Loss of powerthe device lost power | 3 | 1% | 1.1% |
| Charging problem | 2 | 0.7% | 0.5% |
| Detachment of device component | 2 | 0.7% | 1.6% |
| Device dislodged or dislocated | 2 | 0.7% | 1.4% |
| Failure to align | 2 | 0.7% | 0.5% |
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 | 15 | 5.2% |
| Capsular bag tear | 9 | 3.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 1.4% |
| Inflammationinflammation | 2 | 0.7% |
| Injurya physical injury | 2 | 0.7% |
| Intraocular pressure increasedraised pressure in the eye | 2 | 0.7% |
| Vitrectomy | 2 | 0.7% |
| Bone fracture(s) | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
| Electric shockan electric shock | 1 | 0.3% |
| Skin tears | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | LuxOR Ophthalmic Microscopes | Product code HRM | All MAUDE reports |
|---|---|---|---|
| Reports | 289 | 370 | 26,136,888 |
| Share of that pool | — | 78.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 9% | 17.6% | 36.2% |
| Classified as malfunction | 91% | 80.3% | 62.3% |
| Filed by the manufacturer | 100% | 93.2% | 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."
Questions about LuxOR Ophthalmic Microscopes reports
How many FDA reports name LuxOR Ophthalmic Microscopes?
289 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 45 in the latest 12 months.
What kinds of events are reported?
malfunction (91%) and injury (9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loose or intermittent connection (39.8%), unintended movement (32.9%), break (3.5%), device operates differently than expected (2.8%) and device slipped (2.8%). 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 LuxOR Ophthalmic Microscopes 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.