Device brand name · Knife ophthalmic
Alcon Surgical Knife/Blade: medical device reports filed with FDA
220 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Alcon Precision Device. Product code HNN.
- 220
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 30
- reports, 12 months to August 2026
- 17 in the 12 months before
- 92.3%
- classified as malfunction
- 95% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
220 medical device reports received by FDA name the brand "Alcon Surgical Knife/Blade" (knife ophthalmic); the manufacturer given most often on reports is Alcon Research - Alcon Precision Device; received from February 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
30 reports arrived in the 12 months to August 2026, up 76% from 17 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 (92.3%) and injury (7.7%); across all knife, ophthalmic reports (product code HNN) death is recorded in 0% and malfunction in 95%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are dull, blunt (66.8%), material twisted/bent (5.9%) and failure to cut (3.6%). The patient problems coded most often are foreign body in patient, inflammation 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 7,553 reports carrying product code HNN. 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 |
|---|---|---|---|
| Dull, blunt | 147 | 66.8% | 75.8% |
| Material twisted/bent | 13 | 5.9% | 1% |
| Failure to cut | 8 | 3.6% | 7.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 2.7% | 1.4% |
| Metal shedding debris | 6 | 2.7% | 0.5% |
| Material fragmentation | 5 | 2.3% | 0.7% |
| Particulates | 4 | 1.8% | 1.2% |
| Product quality problem | 4 | 1.8% | 0.4% |
| Breakthe device broke | 2 | 0.9% | 0.4% |
| Insufficient device problem information | 2 | 0.9% | 0.3% |
| Bent | 1 | 0.5% | 0.6% |
| Defective devicethe device was defective | 1 | 0.5% | 0.2% |
| Device inoperablethe device could not be used | 1 | 0.5% | 0.1% |
| Improper or incorrect procedure or method | 1 | 0.5% | 0.1% |
| Inadequacy of device shape and/or size | 1 | 0.5% | 0.3% |
| Intermittent continuity | 1 | 0.5% | 0% |
| Material disintegration | 1 | 0.5% | 0.1% |
| Material protrusion/extrusion | 1 | 0.5% | 0.2% |
| Physical resistance | 1 | 0.5% | 0% |
| Residue after decontamination | 1 | 0.5% | 0% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 9 | 4.1% |
| Inflammationinflammation | 7 | 3.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 2.3% |
| Device embedded in tissue or plaque | 4 | 1.8% |
| Wound dehiscencea wound reopened | 2 | 0.9% |
| Blurred vision | 1 | 0.5% |
| Discharge | 1 | 0.5% |
| Endophthalmitisinfection inside the eye | 1 | 0.5% |
| Eye injury | 1 | 0.5% |
| Failure to anastomose | 1 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.5% |
| Injurya physical injury | 1 | 0.5% |
| Laceration(s) | 1 | 0.5% |
| No patient involvement | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alcon Surgical Knife/Blade | Product code HNN | All MAUDE reports |
|---|---|---|---|
| Reports | 220 | 7,553 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 7.7% | 4.7% | 36.2% |
| Classified as malfunction | 92.3% | 95% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 HNN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| ClearCut Knives | 3,409 | 379 | 0% |
| ClearCut Intrepid Knives | 1,059 | 132 | 0% |
| Knife | 848 | 0 | 0% |
| A-OK Ophthalmic Knives | 496 | 31 | 0% |
| V-LANCE Knives | 323 | 37 | 0% |
| Clearcut S Incisional Instruments With Sharps Injury Protection | 180 | 10 | 0% |
| Millennium Microsurgical System | 152 | 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 Alcon Surgical Knife/Blade reports
How many FDA reports name Alcon Surgical Knife/Blade?
220 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 30 in the latest 12 months.
What kinds of events are reported?
malfunction (92.3%) and injury (7.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
dull, blunt (66.8%), material twisted/bent (5.9%), failure to cut (3.6%), device operates differently than expected (2.7%) and metal shedding debris (2.7%). 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 Alcon Surgical Knife/Blade 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.