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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §886.4360 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Device, Irrigation, Ocular Surgery LIGHT-BOOK · MAUDE

#483 of 1000 · 2,143 reports · 1994–2026

  • BOOK 2,143 reports
  • RANK #483 of 1000
  • DEATH 0 death-typed
  • INJ 545 injury-typed
  • MALF 1,588 malfunction
  • SPAN 1994–2026
  • PEAK 2012: 332
  • PHOTO Catheter, Septostomy

Nearest event-volume peer: Catheter, Septostomy (1 report gap)

Device, Irrigation, Ocular Surgery sits #483 of 1000 among tracked device types with 2,143 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 →

Malfunction reports run above the device-type norm

Device, Irrigation, Ocular Surgery carries 74.1% MALFUNCTION-coded reports, 9.3pp 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 25.4% corpus 30.3% · below corpus mean (-4.9 pp)
  • MALF 74.1% corpus 64.8% · above corpus mean (+9.3 pp)

Lead product-problem code Dull, Blunt is 18% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - ALCON PRECISION DEVICE accounts for 80% 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 2,143 MAUDE reports, ranked #483 of 1000.

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

Event Types

Malfunction 1,588 (74.1%)
Injury 545 (25.4%)
Other 6 (0.3%)
4 (0.2%)

Patient Outcomes

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

1,333 (60.9%)
Other 480 (21.9%)
Required Intervention 306 (14.0%)
R 28 (1.3%)
Hospitalization 19 (0.9%)
O 11 (0.5%)
S 6 (0.3%)
Disability 5 (0.2%)

Top Product Problems

Dull, Blunt 295
Failure to Cut 197
Device Contamination with Chemical or Other Material 183
Adverse Event Without Identified Device or Use Problem 148
Fitting Problem 97
Device Issue 96
Break 78
Foreign material 70
Unknown (for use when the device problem is not known) 68
Particulates 58
Fluid/Blood Leak 57
Suction Failure 51
Disconnection 47
Replace 40
Material Twisted/Bent 37
Detachment Of Device Component 35
Connection Problem 32
Sharp Edges 30
Detachment of Device or Device Component 26
Appropriate Device Problem Term/Code Not Available 25

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: 73
26
2026: 48

Reports in 2025 (73) held close to the prior two-year average of 57.

Related Entities for Device, Irrigation, Ocular Surgery

Top Manufacturers

ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 258
BAUSCH & LOMB 65

Event Locations

1,788 (83.4%)
INVALID DATA 103 (4.8%)
I 79 (3.7%)
HOSPITAL 69 (3.2%)
NOT APPLICABLE 46 (2.1%)
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 →

Nationwide devices with a comparable report-volume footprint

Device, Irrigation, Ocular Surgery 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 (2,143 here).

Catheter, Septostomy 2,144 Bottle, Collection, Vacuum 2,145 Cutaneous Tissue Adhesive With Mesh 2,139 Pancreatic Stent 2,138

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.