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2026 data FDA MAUDE openFDA FDA Class I

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

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 §878.4700 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Microscope LIGHT-BOOK · MAUDE

#998 of 1000 · 366 reports · 1994–2026

  • BOOK 366 reports
  • RANK #998 of 1000
  • DEATH 0 death-typed
  • INJ 65 injury-typed
  • MALF 293 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 56
  • PHOTO Balloon Aortic Valvul…

Nearest event-volume peer: Balloon Aortic Valvuloplasty (1 report gap)

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic sits #998 of 1000 among tracked device types with 366 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

Microscope carries 80.1% MALFUNCTION-coded reports, 15.2pp 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 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
  • MALF 80.1% corpus 64.8% · above corpus mean (+15.2 pp)

Lead product-problem code Loose or Intermittent Connection is 34% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 72% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Microscope in the event-volume neighbourhood

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

reports

What this shows Microscope, Operating & Accessories, Ac-Powered, Ophthalmic carries 366 MAUDE reports, ranked #998 of 1000.

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

Event Types

Malfunction 293 (80.1%)
Injury 65 (17.8%)
Other 7 (1.9%)
1 (0.3%)

Patient Outcomes

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

223 (59.2%)
Other 102 (27.1%)
Required Intervention 33 (8.8%)
R 7 (1.9%)
Hospitalization 5 (1.3%)
O 4 (1.1%)
Disability 2 (0.5%)
S 1 (0.3%)

Top Product Problems

Loose or Intermittent Connection 117
Unintended Movement 95
Component Falling 16
Device Operates Differently Than Expected 14
Break 13
Appropriate Device Problem Term/Code Not Available 9
Optical Problem 9
Device Slipped 8
Device Displays Incorrect Message 7
Defective Component 6
Detachment Of Device Component 6
Detachment of Device or Device Component 6
Misfocusing 6
Adverse Event Without Identified Device or Use Problem 5
Device Dislodged or Dislocated 5
Mechanics Altered 5
Unstable 5
Use of Device Problem 5
Device Inoperable 4
Loss of Power 4

Yearly Trend

94
1994: 1
95
1995: 2
96
1996: 5
97
1997: 3
99
1999: 3
00
2000: 1
01
2001: 1
02
2002: 1
04
2004: 3
06
2006: 1
07
2007: 1
08
2008: 1
13
2013: 3
14
2014: 3
15
2015: 29
16
2016: 25
17
2017: 29
18
2018: 30
19
2019: 23
20
2020: 27
21
2021: 24
22
2022: 17
23
2023: 23
24
2024: 33
25
2025: 56
26
2026: 21

Reports rose to 56 in 2025, up from an average of 28 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

Top Manufacturers

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 191
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 73
ALCON - IRVINE TECHNOLOGY CENTER 3

Event Locations

177 (48.4%)
I 168 (45.9%)
HOSPITAL 15 (4.1%)
INVALID DATA 2 (0.5%)
OTHER 2 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.3%)
NO INFORMATION 1 (0.3%)

Compare ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER vs ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER →

Nationwide devices with a comparable report-volume footprint

Microscope 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 (366 here).

Balloon Aortic Valvuloplasty 367 Mediastinoscope, Surgical 364 Temporary Catheter 364 Light, Surgical, Accessories 369

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 Microscope 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 Microscope; 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.