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2026 data FDA MAUDE openFDA

Laser, 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.

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FDA MAUDE casebook

openFDA event book Laser, Ophthalmic LIGHT-BOOK · MAUDE

#557 of 1000 · 1,492 reports · 1992–2026

  • BOOK 1,492 reports
  • RANK #557 of 1000
  • DEATH 0 death-typed
  • INJ 425 injury-typed
  • MALF 1,020 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 111
  • PHOTO Device

Nearest event-volume peer: Device, Removal, Pacemaker Electrode, Percutaneous (4 report gap)

Laser, Ophthalmic sits #557 of 1000 among tracked device types with 1,492 MAUDE reports spanning 1992–2026. 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 28.5% corpus 30.4% · below corpus mean (-2.0 pp)
  • MALF 68.4% corpus 64.5% · above corpus mean (+3.9 pp)

Lead product-problem code Energy Output Problem is 26% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 53% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Laser, Ophthalmic in the event-volume neighbourhood

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

reports

What this shows Laser, Ophthalmic carries 1,492 MAUDE reports, ranked #557 of 1000.

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

Event Types

Malfunction 1,020 (68.4%)
Injury 425 (28.5%)
Other 34 (2.3%)
11 (0.7%)
No answer provided 2 (0.1%)

Patient Outcomes

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

809 (52.5%)
Other 469 (30.4%)
Required Intervention 178 (11.6%)
R 29 (1.9%)
Disability 27 (1.8%)
O 10 (0.6%)
S 10 (0.6%)
Hospitalization 3 (0.2%)
H 2 (0.1%)
Life Threatening 2 (0.1%)
L 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Energy Output Problem 211
Adverse Event Without Identified Device or Use Problem 128
Failure to Fire 66
Power Problem 60
Device Operates Differently Than Expected 53
Appropriate Term/Code Not Available 46
Output below Specifications 45
Failure to Deliver Energy 29
Unexpected Therapeutic Results 22
Loss of Power 21
Output Problem 20
Unexpected Shutdown 18
Insufficient Information 17
Use of Device Problem 14
Electrical /Electronic Property Problem 13
Firing Problem 12
Therapeutic or Diagnostic Output Failure 11
Device Operational Issue 10
Intermittent Energy Output 10
Misfocusing 10

Yearly Trend

92
1992: 2
94
1994: 5
95
1995: 6
96
1996: 10
97
1997: 19
98
1998: 17
99
1999: 11
00
2000: 8
01
2001: 3
02
2002: 30
03
2003: 5
04
2004: 8
05
2005: 12
06
2006: 47
07
2007: 60
08
2008: 34
09
2009: 33
10
2010: 43
11
2011: 26
12
2012: 41
13
2013: 39
14
2014: 58
15
2015: 80
16
2016: 108
17
2017: 77
18
2018: 82
19
2019: 66
20
2020: 72
21
2021: 100
22
2022: 111
23
2023: 92
24
2024: 75
25
2025: 106
26
2026: 6

Related Entities for Laser, Ophthalmic

Top Manufacturers

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 429
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 221
ALCON - IRVINE TECHNOLOGY CENTER 153

Event Locations

823 (55.2%)
I 507 (34.0%)
HOSPITAL 82 (5.5%)
UNKNOWN 25 (1.7%)
NO INFORMATION 17 (1.1%)
AMBULATORY SURGICAL FACILITY 10 (0.7%)
OUTPATIENT TREATMENT FACILITY 10 (0.7%)
INVALID DATA 8 (0.5%)
HOME 5 (0.3%)
OTHER 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
NOT APPLICABLE 1 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Laser, Ophthalmic, 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 (1,492 here).

Device 1,488 Screw, Fixation, Intraosseous 1,485 Mesh 1,501 Integrated Continuous Glucose Monitoring Sy… 1,477

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 Laser, Ophthalmic 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 Laser, Ophthalmic; 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.