PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §886.4390 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Laser, Ophthalmic LIGHT-BOOK · MAUDE

#565 of 1000 · 1,525 reports · 1992–2026

  • BOOK 1,525 reports
  • RANK #565 of 1000
  • DEATH 0 death-typed
  • INJ 430 injury-typed
  • MALF 1,048 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 111
  • PHOTO Confocal Optical Imag…

Nearest event-volume peer: Confocal Optical Imaging (0 report gap)

Laser, Ophthalmic sits #565 of 1000 among tracked device types with 1,525 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 →

Malfunction reports run above the device-type norm

Laser, Ophthalmic carries 68.7% MALFUNCTION-coded reports, 3.9pp 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 28.2% corpus 30.3% · below corpus mean (-2.1 pp)
  • MALF 68.7% corpus 64.8% · above corpus mean (+3.9 pp)

Lead product-problem code Energy Output Problem is 18% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 55% of manufacturer-tagged reports · Top event location is 56% 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 1,525 MAUDE reports, ranked #565 of 1000.

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

Event Types

Malfunction 1,048 (68.7%)
Injury 430 (28.2%)
Other 34 (2.2%)
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.

840 (53.2%)
Other 473 (30.0%)
Required Intervention 179 (11.3%)
R 31 (2.0%)
Disability 27 (1.7%)
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 228
Adverse Event Without Identified Device or Use Problem 133
Device Operates Differently Than Expected 117
Failure to Fire 105
Unknown (for use when the device problem is not known) 96
Normal 73
Power Problem 72
Appropriate Device Problem Term/Code Not Available 67
Device Displays Incorrect Message 62
Output below Specifications 50
Failure to Deliver Energy 47
Loss of Power 43
Insufficient Device Problem Information 39
Device Operational Issue 33
Output Problem 26
Device Inoperable 24
Unexpected Therapeutic Results 23
Use of Device Problem 22
Unexpected Shutdown 18
Nonstandard Device 17

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: 39

Reports in 2025 (106) held close to the prior two-year average of 84.

Related Entities for Laser, Ophthalmic

Top Manufacturers

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 457
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 221
ALCON - IRVINE TECHNOLOGY CENTER 153

Event Locations

855 (56.1%)
I 507 (33.2%)
HOSPITAL 83 (5.4%)
UNKNOWN 25 (1.6%)
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 a comparable report-volume footprint

Laser, Ophthalmic 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 (1,525 here).

Confocal Optical Imaging 1,525 Screw, Fixation, Intraosseous 1,522 Mesh 1,516 Continuous Glucose Monitor 1,514

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.