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2026 data FDA MAUDE openFDA FDA Class I

Scissors, 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).

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FDA MAUDE casebook

openFDA event book Scissors, Ophthalmic LIGHT-BOOK · MAUDE

#984 of 1000 · 385 reports · 1992–2026

  • BOOK 385 reports
  • RANK #984 of 1000
  • DEATH 0 death-typed
  • INJ 66 injury-typed
  • MALF 309 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 57
  • PHOTO Blood Pump For Ecmo

Nearest event-volume peer: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use (1 report gap)

Scissors, Ophthalmic sits #984 of 1000 among tracked device types with 385 MAUDE reports spanning 1992–2026. 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

Scissors, Ophthalmic carries 80.3% MALFUNCTION-coded reports, 15.4pp 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 17.1% corpus 30.3% · below corpus mean (-13.1 pp)
  • MALF 80.3% corpus 64.8% · above corpus mean (+15.4 pp)

Lead product-problem code Break is 49% of coded problems · Lead manufacturer ALCON LABORATORIES, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Scissors, Ophthalmic in the event-volume neighbourhood

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

reports

What this shows Scissors, Ophthalmic carries 385 MAUDE reports, ranked #984 of 1000.

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

Event Types

Malfunction 309 (80.3%)
Injury 66 (17.1%)
Other 7 (1.8%)
3 (0.8%)

Patient Outcomes

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

233 (52.7%)
Other 102 (23.1%)
Required Intervention 41 (9.3%)
H 26 (5.9%)
R 20 (4.5%)
O 14 (3.2%)
Hospitalization 6 (1.4%)

Top Product Problems

Break 194
Difficult to Open or Close 45
Adverse Event Without Identified Device or Use Problem 41
Detachment Of Device Component 22
Failure to Cut 19
Tip breakage 10
Component Falling 9
Detachment of Device or Device Component 8
Dull, Blunt 7
Corroded 6
Mechanical Jam 6
Insufficient Device Problem Information 5
Material Separation 5
Device Inoperable 4
Material Fragmentation 4
Other (for use when an appropriate device code cannot be identified) 4
Defective Device 3
Device Operates Differently Than Expected 3
Component(s), broken 2
Crack 2

Yearly Trend

92
1992: 2
94
1994: 2
96
1996: 7
97
1997: 20
98
1998: 10
99
1999: 1
00
2000: 2
01
2001: 1
02
2002: 5
03
2003: 1
04
2004: 1
06
2006: 2
07
2007: 2
08
2008: 7
10
2010: 4
11
2011: 12
12
2012: 31
13
2013: 29
14
2014: 20
15
2015: 18
16
2016: 10
17
2017: 5
18
2018: 9
19
2019: 19
20
2020: 10
21
2021: 18
22
2022: 20
23
2023: 57
24
2024: 30
25
2025: 21
26
2026: 9

Reports fell to 21 in 2025, down from an average of 44 in the two years before.

Related Entities for Scissors, Ophthalmic

Top Manufacturers

ALCON LABORATORIES, INC. 5

Event Locations

264 (68.6%)
I 64 (16.6%)
HOSPITAL 32 (8.3%)
AMBULATORY SURGICAL FACILITY 6 (1.6%)
OTHER 5 (1.3%)
OUTPATIENT TREATMENT FACILITY 5 (1.3%)
INVALID DATA 4 (1.0%)
NO INFORMATION 4 (1.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.3%)

Nationwide devices with a comparable report-volume footprint

Scissors, 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 (385 here).

Blood Pump For Ecmo, Long-Term Use 386 Catheter, Cholangiography 386 Indicator 386 Refrigerator, Freezer, Blood Storage 383

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 Scissors, 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 Scissors, 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.