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Scissors, Ophthalmic

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Scissors, Ophthalmic

The FDA MAUDE database aggregates 378 adverse-event reports for Scissors, Ophthalmic spanning the period from 1992 through 2026. Of these, 0 are classified as death reports, 66 as injury reports, and 302 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 4 distinct event types and 7 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 66 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 57 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 9 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

378
Total Reports
0
Death Reports
66
Injury Reports
302
Malfunctions

Event Types

Malfunction 302 (79.9%)
Injury 66 (17.5%)
Other 7 (1.9%)
3 (0.8%)

Patient Outcomes

228 (52.2%)
Other 102 (23.3%)
Required Intervention 41 (9.4%)
H 26 (5.9%)
R 20 (4.6%)
O 14 (3.2%)
Hospitalization 6 (1.4%)

Top Product Problems

Break 66
Difficult to Open or Close 42
Adverse Event Without Identified Device or Use Problem 41
Failure to Cut 17
Dull, Blunt 5
Mechanical Jam 5
Insufficient Information 4
Material Fragmentation 4
Corroded 3
Defective Device 3
Detachment of Device or Device Component 3
Device Fell 2
Device Operates Differently Than Expected 2
Fitting Problem 2
Loose or Intermittent Connection 2
Material Frayed 2
Material Separation 2
Mechanical Problem 2
Physical Resistance/Sticking 2
Positioning Problem 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: 2

Related Entities for Scissors, Ophthalmic

Event Locations

257 (68.0%)
I 64 (16.9%)
HOSPITAL 32 (8.5%)
AMBULATORY SURGICAL FACILITY 6 (1.6%)
OTHER 5 (1.3%)
OUTPATIENT TREATMENT FACILITY 5 (1.3%)
INVALID DATA 4 (1.1%)
NO INFORMATION 4 (1.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.3%)

Compare ALCON GRIESHABER AG vs MICROSURGICAL TECHNOLOGY, INC. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.