2026 data FDA MAUDE openFDA FDA Class III

Excimer Laser System

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 MAUDE casebook

openFDA event book Excimer Laser System MID-BOOK · MAUDE

#184 of 1000 · 13,777 reports · 1994–2026

  • BOOK 13,777 reports
  • RANK #184 of 1000
  • DEATH 12 death-typed
  • INJ 11,659 injury-typed
  • MALF 1,933 malfunction
  • SPAN 1994–2026
  • PEAK 2014: 1,803
  • PHOTO Catheter, Steerable

Nearest event-volume peer: Catheter, Steerable (27 report gap)

Excimer Laser System sits #184 of 1000 among tracked device types with 13,777 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 →

Injury-coded reports run above the device-type norm

Excimer Laser System carries 84.6% INJURY-coded reports, 54.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 84.6% corpus 30.3% · above corpus mean (+54.3 pp)
  • MALF 14.0% corpus 64.8% · below corpus mean (-50.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 53% of coded problems · Lead manufacturer WAVELIGHT GMBH accounts for 87% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Excimer Laser System in the event-volume neighbourhood

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

reports

What this shows Excimer Laser System carries 13,777 MAUDE reports, ranked #184 of 1000.

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

Event Types

Injury 11,659 (84.6%)
Malfunction 1,933 (14.0%)
Other 126 (0.9%)
46 (0.3%)
Death 12 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Required Intervention 6,125 (42.3%)
Other 5,234 (36.2%)
1,777 (12.3%)
Disability 551 (3.8%)
R 324 (2.2%)
S 230 (1.6%)
O 117 (0.8%)
Hospitalization 45 (0.3%)
Life Threatening 34 (0.2%)
L 12 (0.1%)
Death 10 (0.1%)
H 9 (0.1%)
Congenital Anomaly 4 (0.0%)
D 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 6,714
Insufficient Device Problem Information 1,853
Unknown (for use when the device problem is not known) 1,370
Device Operates Differently Than Expected 552
Device Displays Incorrect Message 403
Appropriate Device Problem Term/Code Not Available 263
Improper or Incorrect Procedure or Method 208
Patient-Device Incompatibility 179
Energy Output Problem 158
Overcorrection 156
Failure to Fire 151
Unexpected Therapeutic Results 149
Computer Software Problem 94
Failure to Align 86
Therapeutic or Diagnostic Output Failure 82
Gas/Air Leak 80
Use of Device Problem 74
Device Inoperable 66
Other (for use when an appropriate device code cannot be identified) 65
Failure to Capture 56

Yearly Trend

94
1994: 1
95
1995: 1
96
1996: 2
97
1997: 13
98
1998: 8
99
1999: 21
00
2000: 54
01
2001: 25
02
2002: 19
03
2003: 20
04
2004: 22
05
2005: 101
06
2006: 190
07
2007: 516
08
2008: 588
09
2009: 266
10
2010: 697
11
2011: 462
12
2012: 477
13
2013: 944
14
2014: 1,803
15
2015: 1,146
16
2016: 808
17
2017: 1,360
18
2018: 1,601
19
2019: 1,063
20
2020: 565
21
2021: 266
22
2022: 152
23
2023: 128
24
2024: 109
25
2025: 281
26
2026: 68

Reports rose to 281 in 2025, up from an average of 119 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Excimer Laser System

Event Locations

7,263 (52.7%)
I 5,522 (40.1%)
NO INFORMATION 482 (3.5%)
OUTPATIENT TREATMENT FACILITY 183 (1.3%)
OTHER 178 (1.3%)
UNKNOWN 93 (0.7%)
HOSPITAL 21 (0.2%)
AMBULATORY SURGICAL FACILITY 18 (0.1%)
HOME 8 (0.1%)
INVALID DATA 4 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)

Compare WAVELIGHT GMBH vs ABBOTT MEDICAL OPTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Excimer Laser System: 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 (13,777 here).

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Disclaimer: MAUDE figures for Excimer Laser System 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 Excimer Laser System; 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.