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2026 data FDA MAUDE openFDA

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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 Instrument LIGHT-BOOK · MAUDE

#286 of 1000 · 5,802 reports · 1993–2026

  • BOOK 5,802 reports
  • RANK #286 of 1000
  • DEATH 2 death-typed
  • INJ 2,519 injury-typed
  • MALF 3,196 malfunction
  • SPAN 1993–2026
  • PEAK 1998: 688
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (24 report gap)

Instrument, Vitreous Aspiration And Cutting, Ac-Powered sits #286 of 1000 among tracked device types with 5,802 MAUDE reports spanning 1993–2026. 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 43.4% corpus 30.4% · above corpus mean (+13.0 pp)
  • MALF 55.1% corpus 64.5% · below corpus mean (-9.4 pp)

Lead product-problem code Fitting Problem is 24% of coded problems · Lead manufacturer ALCON - IRVINE TECHNOLOGY CENTER accounts for 40% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Instrument in the event-volume neighbourhood

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

reports

What this shows Instrument, Vitreous Aspiration And Cutting, Ac-Powered carries 5,802 MAUDE reports, ranked #286 of 1000.

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

Event Types

Malfunction 3,196 (55.1%)
Injury 2,519 (43.4%)
Other 62 (1.1%)
23 (0.4%)
Death 2 (0.0%)

Patient Outcomes

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

2,955 (49.8%)
Required Intervention 1,599 (26.9%)
Other 1,151 (19.4%)
R 93 (1.6%)
Hospitalization 66 (1.1%)
S 28 (0.5%)
Disability 27 (0.5%)
O 8 (0.1%)
Death 3 (0.1%)
H 2 (0.0%)
Life Threatening 2 (0.0%)

Top Product Problems

Fitting Problem 257
Failure to Cut 186
Adverse Event Without Identified Device or Use Problem 142
Difficult to Insert 100
Device Operational Issue 72
Suction Problem 50
Suction Failure 43
Defective Component 28
Device Operates Differently Than Expected 23
Failure to Advance 23
Sticking 21
Break 18
Physical Resistance/Sticking 14
Improper Flow or Infusion 12
Particulates 12
Detachment of Device or Device Component 11
Device Contamination with Chemical or Other Material 11
Fluid/Blood Leak 10
Material Separation 10
Material Deformation 8

Yearly Trend

93
1993: 4
94
1994: 10
95
1995: 12
96
1996: 173
97
1997: 507
98
1998: 688
99
1999: 415
00
2000: 382
01
2001: 451
02
2002: 390
03
2003: 274
04
2004: 301
05
2005: 183
06
2006: 383
07
2007: 300
08
2008: 65
09
2009: 34
10
2010: 27
11
2011: 21
12
2012: 34
13
2013: 9
14
2014: 9
15
2015: 9
16
2016: 10
17
2017: 59
18
2018: 309
19
2019: 41
20
2020: 30
21
2021: 32
22
2022: 46
23
2023: 108
24
2024: 105
25
2025: 341
26
2026: 40

Related Entities for Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Top Manufacturers

ALCON - IRVINE TECHNOLOGY CENTER 1,468
ALCON LABORATORIES, INC. 1,046
ALCON-IRVINE TECHNOLOGY CENTER 307
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 252
ALCON RESEARCH, LLC - HOUSTON 229
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 220
ALCON LABORATORIES, INC 126

Event Locations

3,366 (58.0%)
HOSPITAL 1,379 (23.8%)
I 475 (8.2%)
AMBULATORY SURGICAL FACILITY 354 (6.1%)
OUTPATIENT TREATMENT FACILITY 112 (1.9%)
INVALID DATA 52 (0.9%)
UNKNOWN 26 (0.4%)
NO INFORMATION 19 (0.3%)
OTHER 11 (0.2%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
HOME 2 (0.0%)
NURSING HOME 2 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ALCON - IRVINE TECHNOLOGY CENTER vs ALCON LABORATORIES, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, 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 (5,802 here).

Mesh 5,826 Catheter 5,832 Catheter 5,758 Holder, Head, Neurosurgical 5,752

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Instrument 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 Instrument; 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.