Device brand name · Manual ophthalmic surgical instrument
Knife: medical device reports filed with FDA
848 reports name it, 2002–2015. Manufacturer given most often on reports: Alcon Precision Device - Sinking Spring. Product code HNN.
- 848
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 94.7%
- classified as malfunction
- 95% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
848 medical device reports received by FDA name the brand "Knife" (manual ophthalmic surgical instrument); the manufacturer given most often on reports is Alcon Precision Device - Sinking Spring; received from January 2002 to February 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (94.7%), injury (4.6%) and other (0.7%); 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 (78.5%), failure to cut (13.1%) and bent (2.5%). The patient problems coded most often are no patient involvement, foreign body in patient and eye injury. 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 Knife was received in the five years to August 2026; the latest was received in February 2015.
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 | 666 | 78.5% | 75.8% |
| Failure to cut | 111 | 13.1% | 7.3% |
| Bent | 21 | 2.5% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 0.8% | 1.4% |
| Device damaged prior to usethe device was damaged before use | 5 | 0.6% | 0.1% |
| Material deformation | 5 | 0.6% | 0.3% |
| Metal shedding debris | 5 | 0.6% | 0.5% |
| Product quality problem | 5 | 0.6% | 0.4% |
| Device contamination with chemical or other material | 4 | 0.5% | 0.2% |
| Particulates | 3 | 0.4% | 1.2% |
| Device issuea problem with the device | 2 | 0.2% | 0.2% |
| Device misassembled during manufacturing /shipping | 2 | 0.2% | 0% |
| Misassembled | 2 | 0.2% | 0.1% |
| Nonstandard device | 2 | 0.2% | 0% |
| Breakthe device broke | 1 | 0.1% | 0.4% |
| Defective component | 1 | 0.1% | 0.2% |
| Defective devicethe device was defective | 1 | 0.1% | 0.2% |
| Dent in material | 1 | 0.1% | 0% |
| Device operational issue | 1 | 0.1% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.1% | 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 | 22 | 2.6% |
| Foreign body in patientpart of a device left in the patient | 7 | 0.8% |
| Eye injury | 5 | 0.6% |
| Laceration(s) | 3 | 0.4% |
| Capsular bag tear | 2 | 0.2% |
| Eye burn | 2 | 0.2% |
| Postoperative refraction, unexpected | 2 | 0.2% |
| Collapse | 1 | 0.1% |
| Corneal edema | 1 | 0.1% |
| Corneal stromal edema | 1 | 0.1% |
| Foreign body, removal of | 1 | 0.1% |
| Inflammationinflammation | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
| Keratitis | 1 | 0.1% |
| Perforation | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Knife | Product code HNN | All MAUDE reports |
|---|---|---|---|
| Reports | 848 | 7,553 | 26,136,888 |
| Share of that pool | — | 11.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 4.6% | 4.7% | 36.2% |
| Classified as malfunction | 94.7% | 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% |
| A-OK Ophthalmic Knives | 496 | 31 | 0% |
| V-LANCE Knives | 323 | 37 | 0% |
| Alcon Surgical Knife/Blade | 220 | 30 | 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 Knife reports
How many FDA reports name Knife?
848 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 (94.7%), injury (4.6%) and other (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
dull, blunt (78.5%), failure to cut (13.1%), bent (2.5%), device operates differently than expected (0.8%) and device damaged prior to use (0.6%). 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 Knife 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.