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2026 data FDA MAUDE openFDA

Device, Irrigation, Ocular Surgery

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 Device, Irrigation, Ocular Surgery LIGHT-BOOK · MAUDE

#470 of 1000 · 2,106 reports · 1994–2026

  • BOOK 2,106 reports
  • RANK #470 of 1000
  • DEATH 0 death-typed
  • INJ 543 injury-typed
  • MALF 1,553 malfunction
  • SPAN 1994–2026
  • PEAK 2012: 332
  • PHOTO Pulmonary Valve Prost…

Nearest event-volume peer: Pulmonary Valve Prosthesis Percutaneously Delivered (2 report gap)

Device, Irrigation, Ocular Surgery sits #470 of 1000 among tracked device types with 2,106 MAUDE reports spanning 1994–2026. 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 25.8% corpus 30.4% · below corpus mean (-4.7 pp)
  • MALF 73.7% corpus 64.5% · above corpus mean (+9.2 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - ALCON PRECISION DEVICE accounts for 59% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .

Device, Irrigation, Ocular Surgery in the event-volume neighbourhood

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

reports

What this shows Device, Irrigation, Ocular Surgery carries 2,106 MAUDE reports, ranked #470 of 1000.

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

Event Types

Malfunction 1,553 (73.7%)
Injury 543 (25.8%)
Other 6 (0.3%)
4 (0.2%)

Patient Outcomes

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

1,298 (60.4%)
Other 478 (22.2%)
Required Intervention 305 (14.2%)
R 28 (1.3%)
Hospitalization 19 (0.9%)
O 10 (0.5%)
S 6 (0.3%)
Disability 5 (0.2%)

Top Product Problems

Break 53
Adverse Event Without Identified Device or Use Problem 38
Suction Failure 34
Material Twisted/Bent 28
Sharp Edges 27
Complete Blockage 20
Component Missing 14
Delivered as Unsterile Product 14
Misassembled 14
Obstruction of Flow 14
Decrease in Suction 6
Scratched Material 6
Appropriate Term/Code Not Available 5
Detachment of Device or Device Component 5
Insufficient Information 5
Suction Problem 5
Defective Device 4
Device Operates Differently Than Expected 4
Material Integrity Problem 4
Defective Component 3

Yearly Trend

94
1994: 5
95
1995: 4
96
1996: 33
97
1997: 177
98
1998: 3
99
1999: 6
00
2000: 81
01
2001: 5
02
2002: 10
03
2003: 21
04
2004: 57
05
2005: 29
06
2006: 51
07
2007: 103
08
2008: 61
09
2009: 50
10
2010: 127
11
2011: 81
12
2012: 332
13
2013: 242
14
2014: 258
15
2015: 79
16
2016: 14
17
2017: 10
18
2018: 10
19
2019: 13
20
2020: 8
21
2021: 19
22
2022: 20
23
2023: 23
24
2024: 90
25
2025: 75
26
2026: 9

Related Entities for Device, Irrigation, Ocular Surgery

Top Manufacturers

ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 222
BAUSCH & LOMB, INC. 88
BAUSCH & LOMB 65

Event Locations

1,751 (83.1%)
INVALID DATA 103 (4.9%)
I 79 (3.8%)
HOSPITAL 69 (3.3%)
NOT APPLICABLE 46 (2.2%)
OTHER 38 (1.8%)
AMBULATORY SURGICAL FACILITY 15 (0.7%)
NO INFORMATION 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)

Compare ALCON RESEARCH, LLC - ALCON PRECISION DEVICE vs BAUSCH & LOMB, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Irrigation, Ocular Surgery, 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 (2,106 here).

Pulmonary Valve Prosthesis Percutaneously D… 2,104 Bottle, Collection, Vacuum 2,119 Adaptor 2,084 Calculator/Data Processing Module 2,135

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 Device, Irrigation, Ocular Surgery 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 Device, Irrigation, Ocular Surgery; 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.