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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Knife, Ophthalmic LIGHT-BOOK · MAUDE

#253 of 1000 · 7,239 reports · 1995–2026

  • BOOK 7,239 reports
  • RANK #253 of 1000
  • DEATH 0 death-typed
  • INJ 345 injury-typed
  • MALF 6,873 malfunction
  • SPAN 1995–2026
  • PEAK 2024: 1,844
  • PHOTO Lens

Nearest event-volume peer: Lens, Intraocular, Toric Optics (17 report gap)

Knife, Ophthalmic sits #253 of 1000 among tracked device types with 7,239 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 4.8% corpus 30.4% · below corpus mean (-25.7 pp)
  • MALF 94.9% corpus 64.5% · above corpus mean (+30.4 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 63% of location-tagged rows .

Knife, Ophthalmic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Knife, Ophthalmic carries 7,239 MAUDE reports, ranked #253 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 6,873 (94.9%)
Injury 345 (4.8%)
Other 21 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

5,326 (73.0%)
Other 1,731 (23.7%)
Required Intervention 155 (2.1%)
R 34 (0.5%)
O 30 (0.4%)
Disability 7 (0.1%)
Hospitalization 5 (0.1%)
S 2 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Dull, Blunt 4,473
Fail-Safe Did Not Operate 411
Failure to Cut 350
Adverse Event Without Identified Device or Use Problem 87
Material Twisted/Bent 75
Device Operates Differently Than Expected 62
Particulates 61
Material Fragmentation 51
Fail-Safe Problem 45
Protective Measures Problem 44
Metal Shedding Debris 28
Insufficient Information 26
Bent 22
Material Integrity Problem 21
Appropriate Term/Code Not Available 20
Defective Device 18
Inadequacy of Device Shape and/or Size 17
Break 15
Product Quality Problem 15
Component Misassembled 14

Yearly Trend

95
1995: 3
96
1996: 11
97
1997: 7
98
1998: 6
99
1999: 8
00
2000: 5
01
2001: 6
02
2002: 10
03
2003: 3
04
2004: 19
05
2005: 9
06
2006: 22
07
2007: 21
08
2008: 10
09
2009: 13
10
2010: 149
11
2011: 223
12
2012: 112
13
2013: 173
14
2014: 169
15
2015: 401
16
2016: 435
17
2017: 472
18
2018: 420
19
2019: 291
20
2020: 493
21
2021: 403
22
2022: 327
23
2023: 355
24
2024: 1,844
25
2025: 700
26
2026: 119

Related Entities for Knife, Ophthalmic

Top Manufacturers

ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 3,947
BAUSCH + LOMB 51
ALCON LABORATORIES, INC. 21

Event Locations

4,554 (62.9%)
I 2,567 (35.5%)
HOSPITAL 41 (0.6%)
AMBULATORY SURGICAL FACILITY 32 (0.4%)
NO INFORMATION 29 (0.4%)
OUTPATIENT TREATMENT FACILITY 7 (0.1%)
UNKNOWN 5 (0.1%)
INVALID DATA 4 (0.1%)

Compare ALCON RESEARCH, LLC - ALCON PRECISION DEVICE vs BAUSCH + LOMB →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Knife, Ophthalmic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (7,239 here).

Lens, Intraocular, Toric Optics 7,256 Abutment, Implant, Dental, Endosseous 7,311 Catheter 7,318 Catheter, Ultrasound, Intravascular 7,328

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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.