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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §886.4150 (Ophthalmic panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Instrument LIGHT-BOOK · MAUDE

#289 of 1000 · 5,942 reports · 1993–2026

  • BOOK 5,942 reports
  • RANK #289 of 1000
  • DEATH 2 death-typed
  • INJ 2,522 injury-typed
  • MALF 3,333 malfunction
  • SPAN 1993–2026
  • PEAK 1998: 688
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (4 report gap)

Instrument, Vitreous Aspiration And Cutting, Ac-Powered sits #289 of 1000 among tracked device types with 5,942 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 →

Injury-coded reports run above the device-type norm

Instrument carries 42.4% INJURY-coded reports, 12.2pp 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 42.4% corpus 30.3% · above corpus mean (+12.2 pp)
  • MALF 56.1% corpus 64.8% · below corpus mean (-8.7 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 26% of coded problems · Lead manufacturer ALCON - IRVINE TECHNOLOGY CENTER accounts for 39% of manufacturer-tagged reports · Top event location is 59% 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 5,942 MAUDE reports, ranked #289 of 1000.

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

Event Types

Malfunction 3,333 (56.1%)
Injury 2,522 (42.4%)
Other 62 (1.0%)
23 (0.4%)
Death 2 (0.0%)

Patient Outcomes

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

3,084 (50.8%)
Required Intervention 1,599 (26.3%)
Other 1,159 (19.1%)
R 93 (1.5%)
Hospitalization 66 (1.1%)
S 28 (0.5%)
Disability 27 (0.4%)
O 8 (0.1%)
Death 3 (0.0%)
H 2 (0.0%)
Life Threatening 2 (0.0%)

Top Product Problems

Unknown (for use when the device problem is not known) 1,503
Device Issue 609
Replace 577
Thermal Decomposition of Device 559
Failure to Cut 446
Fitting Problem 268
Other (for use when an appropriate device code cannot be identified) 268
Device Displays Incorrect Message 238
Particulates 153
Adverse Event Without Identified Device or Use Problem 148
Loss of Power 145
Device Inoperable 131
Suction Problem 129
Aspiration, incomplete 115
Difficult to Insert 114
Failure, intermittent 104
Malfunction 103
Inability to Irrigate 91
Occlusion Within Device 87
Device, or device fragments remain in patient 81

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: 180

Reports rose to 341 in 2025, up from an average of 107 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

ALCON - IRVINE TECHNOLOGY CENTER 1,468
ALCON LABORATORIES, INC. 1,050
ALCON RESEARCH, LLC - HOUSTON 320
ALCON-IRVINE TECHNOLOGY CENTER 307
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 264
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 220
ALCON LABORATORIES, INC 126

Event Locations

3,502 (58.9%)
HOSPITAL 1,383 (23.3%)
I 475 (8.0%)
AMBULATORY SURGICAL FACILITY 354 (6.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,942 here).

Catheter 5,946 Stopcock, I.V. Set 5,928 Mesh 5,966 Drug-Eluting Peripheral Transluminal Angiop… 5,888

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 Bed, Pediatric Open Hospital 2 Blade 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.