What are FDA adverse event reports for Excimer Laser System?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Excimer Laser System, there are 13,735 total reports including 10 death reports and 11,624 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Excimer Laser System?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Excimer Laser System

Name: Excimer Laser System - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Excimer Laser System MID-BOOK · MAUDE

#176 of 1000 · 13,735 reports · 1994–2026

BOOK 13,735 reports
RANK #176 of 1000
DEATH 10 death-typed
INJ 11,624 injury-typed
MALF 1,928 malfunction
SPAN 1994–2026
PEAK 2014: 1,803
PHOTO Set

Nearest event-volume peer: Set, I.V. Fluid Transfer (17 report gap)

Excimer Laser System sits #176 of 1000 among tracked device types with 13,735 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 84.6% corpus 30.4% · above corpus mean (+54.2 pp)
MALF 14.0% corpus 64.5% · below corpus mean (-50.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 58% of coded problems · Lead manufacturer WAVELIGHT GMBH accounts for 87% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Lift

13,786
Excimer Laser… (this)

13,735
Set

13,718
Device

13,654
Lens

13,624
Oximeter

13,424

What this shows Excimer Laser System carries 13,735 MAUDE reports, ranked #176 of 1000.

Event Types

Injury 11,624 (84.6%)

Malfunction 1,928 (14.0%)

Other 126 (0.9%)

46 (0.3%)

Death 10 (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 6,112 (42.4%)

Other 5,214 (36.2%)

1,771 (12.3%)

Disability 549 (3.8%)

R 318 (2.2%)

S 230 (1.6%)

O 109 (0.8%)

Hospitalization 45 (0.3%)

Life Threatening 34 (0.2%)

L 12 (0.1%)

H 9 (0.1%)

Death 8 (0.1%)

Congenital Anomaly 4 (0.0%)

D 1 (0.0%)

Yearly Trend

1994: 1

1995: 1

1996: 2

1997: 13

1998: 8

1999: 21

2000: 54

2001: 25

2002: 19

2003: 20

2004: 22

2005: 101

2006: 190

2007: 516

2008: 588

2009: 266

2010: 697

2011: 462

2012: 477

2013: 944

2014: 1,803

2015: 1,146

2016: 808

2017: 1,360

2018: 1,601

2019: 1,063

2020: 565

2021: 266

2022: 152

2023: 128

2024: 109

2025: 281

2026: 26

Top Manufacturers

WAVELIGHT GMBH 8,887

ABBOTT MEDICAL OPTICS 677

UNK 437

JOHNSON & JOHNSON SURGICAL VISION, INC. 150

UNKNOWN 118

Event Locations

7,221 (52.6%)

I 5,522 (40.2%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Excimer Laser System, 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 (13,735 here).

Set, I.V. Fluid Transfer 13,718 Lift, Patient, Non-Ac-Powered 13,786 Device, Vascular, For Promoting Embolization 13,654 Lens, Multifocal Intraocular 13,624

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Cabinet, Table And Tray, Anesthesia 10 Chair, Adjustable, Mechanical 10

Read our methodology - how this data is sourced, computed, and verified.

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.

Excimer Laser System

Event-type mix vs corpus