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2026 data FDA MAUDE openFDA FDA Class II

Vitrectomy, Instrument Cutter

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).

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FDA MAUDE casebook

openFDA event book Vitrectomy, Instrument Cutter LIGHT-BOOK · MAUDE

#692 of 1000 · 899 reports · 1996–2026

  • BOOK 899 reports
  • RANK #692 of 1000
  • DEATH 0 death-typed
  • INJ 55 injury-typed
  • MALF 843 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 256
  • PHOTO Probe

Nearest event-volume peer: Probe, Radiofrequency Lesion (2 report gap)

Vitrectomy, Instrument Cutter sits #692 of 1000 among tracked device types with 899 MAUDE reports spanning 1996–2026. 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

Vitrectomy, Instrument Cutter carries 93.8% MALFUNCTION-coded reports, 28.9pp 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 6.1% corpus 30.3% · below corpus mean (-24.2 pp)
  • MALF 93.8% corpus 64.8% · above corpus mean (+28.9 pp)

Lead product-problem code Failure to Cut is 63% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HOUSTON accounts for 89% of manufacturer-tagged reports · Top event location is 85% of location-tagged rows .

Vitrectomy, Instrument Cutter in the event-volume neighbourhood

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

reports

What this shows Vitrectomy, Instrument Cutter carries 899 MAUDE reports, ranked #692 of 1000.

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

Event Types

Malfunction 843 (93.8%)
Injury 55 (6.1%)
Other 1 (0.1%)

Patient Outcomes

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

825 (91.6%)
Required Intervention 43 (4.8%)
Other 25 (2.8%)
Disability 5 (0.6%)
O 2 (0.2%)
R 1 (0.1%)

Top Product Problems

Failure to Cut 604
Suction Problem 102
Suction Failure 91
Tip breakage 30
Device Issue 27
Device, removal of (non-implant) 18
Break 17
Air/Gas in Device 13
Device Operates Differently Than Expected 9
Material Twisted/Bent 9
Device Markings/Labelling Problem 8
Adverse Event Without Identified Device or Use Problem 5
Complete Blockage 5
Dull, Blunt 5
Contamination 4
Decrease in Suction 4
Defective Device 4
Material Separation 4
Mechanical Problem 4
Ambient Noise Problem 3

Yearly Trend

96
1996: 2
97
1997: 9
01
2001: 3
03
2003: 1
04
2004: 11
05
2005: 13
06
2006: 31
07
2007: 15
08
2008: 5
09
2009: 13
10
2010: 2
11
2011: 1
12
2012: 3
13
2013: 4
14
2014: 2
16
2016: 5
17
2017: 10
18
2018: 8
19
2019: 6
20
2020: 54
21
2021: 40
22
2022: 40
23
2023: 92
24
2024: 188
25
2025: 256
26
2026: 85

Reports rose to 256 in 2025, up from an average of 140 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Vitrectomy, Instrument Cutter

Top Manufacturers

ALCON RESEARCH, LLC - HOUSTON 715
BAUSCH & LOMB 50
ALCON LABORATORIES, INC. 18
ABBOTT MEDICAL OPTICS 6
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 5
Alcon Research, LLC - Houston 5

Event Locations

760 (84.5%)
I 90 (10.0%)
HOSPITAL 30 (3.3%)
AMBULATORY SURGICAL FACILITY 6 (0.7%)
NO INFORMATION 4 (0.4%)
INVALID DATA 3 (0.3%)
NOT APPLICABLE 3 (0.3%)
OTHER 2 (0.2%)
UNKNOWN 1 (0.1%)

Compare ALCON RESEARCH, LLC - HOUSTON vs BAUSCH & LOMB →

Nationwide devices with a comparable report-volume footprint

Vitrectomy, Instrument Cutter 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 (899 here).

Probe, Radiofrequency Lesion 897 Flow Cytometric Reagents And Accessories. 896 Enzyme Immunoassay, Diphenylhydantoin 905 Laparoscopic Contraceptive Tubal Occlusion… 893

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 Vitrectomy, Instrument Cutter 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 Vitrectomy, Instrument Cutter; 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.