Knife, Ophthalmic
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §886.4350 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Knife, Ophthalmic LIGHT-BOOK · MAUDE
#257 of 1000 · 7,502 reports · 1995–2026
- BOOK 7,502 reports
- RANK #257 of 1000
- DEATH 0 death-typed
- INJ 354 injury-typed
- MALF 7,127 malfunction
- SPAN 1995–2026
- PEAK 2024: 1,844
- PHOTO Insufflator
Nearest event-volume peer: Insufflator, Laparoscopic (3 report gap)
Knife, Ophthalmic sits #257 of 1000 among tracked device types with 7,502 MAUDE reports spanning 1995–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Knife, Ophthalmic carries 95.0% MALFUNCTION-coded reports, 30.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 4.7% corpus 30.3% · below corpus mean (-25.6 pp)
- MALF 95.0% corpus 64.8% · above corpus mean (+30.2 pp)
Lead product-problem code Dull, Blunt is 76% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - ALCON PRECISION DEVICE accounts for 98% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .
Knife, Ophthalmic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Nasopharyngos…
Nasopharyngoscope (Flexible Or Rigid)
7,691 reports
- System
System, X-Ray, Angiographic
7,625 reports
- Glucose Oxida…
Glucose Oxidase, Glucose
7,604 reports
- Knife (this)
Knife, Ophthalmic
7,502 reports
- Insufflator
Insufflator, Laparoscopic
7,499 reports
- Laryngoscope
Laryngoscope, Rigid
7,361 reports
What this shows Knife, Ophthalmic carries 7,502 MAUDE reports, ranked #257 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 701 in 2025, down from an average of 1,100 in the two years before.
Related Entities for Knife, Ophthalmic
Top Manufacturers
Event Locations
Compare ALCON RESEARCH, LLC - ALCON PRECISION DEVICE vs BAUSCH + LOMB →
Nationwide devices with a comparable report-volume footprint
Knife, Ophthalmic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (7,502 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Knife, Ophthalmic are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Knife, Ophthalmic; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.