2026 data FDA MAUDE openFDA

Ophthalmic Femtosecond Laser

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 Ophthalmic Femtosecond Laser LIGHT-BOOK · MAUDE

#317 of 1000 · 4,856 reports · 2011–2026

  • BOOK 4,856 reports
  • RANK #317 of 1000
  • DEATH 0 death-typed
  • INJ 2,810 injury-typed
  • MALF 1,962 malfunction
  • SPAN 2011–2026
  • PEAK 2015: 689
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Cleaning, For Endoscope (1 report gap)

Ophthalmic Femtosecond Laser sits #317 of 1000 among tracked device types with 4,856 MAUDE reports spanning 2011–2026. 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 57.9% corpus 30.4% · above corpus mean (+27.4 pp)
  • MALF 40.4% corpus 64.5% · below corpus mean (-24.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer WAVELIGHT GMBH accounts for 40% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .

Ophthalmic Femtosecond Laser in the event-volume neighbourhood

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

reports

What this shows Ophthalmic Femtosecond Laser carries 4,856 MAUDE reports, ranked #317 of 1000.

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

Event Types

Injury 2,810 (57.9%)
Malfunction 1,962 (40.4%)
Other 84 (1.7%)

Patient Outcomes

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

Other 2,318 (43.8%)
1,422 (26.9%)
Required Intervention 1,095 (20.7%)
R 289 (5.5%)
O 140 (2.6%)
Disability 13 (0.2%)
S 5 (0.1%)
Hospitalization 3 (0.1%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,248
Decrease in Suction 561
Failure to Align 380
Insufficient Information 248
Device Operates Differently Than Expected 242
Failure to Cut 181
Appropriate Term/Code Not Available 143
Suction Problem 87
Unintended Movement 38
Patient Device Interaction Problem 33
Therapeutic or Diagnostic Output Failure 31
Unexpected Therapeutic Results 28
Device Displays Incorrect Message 27
Improper or Incorrect Procedure or Method 25
Patient-Device Incompatibility 22
Use of Device Problem 18
Suction Failure 17
Application Program Freezes, Becomes Nonfunctional 16
Break 16
Mechanical Problem 16

Yearly Trend

11
2011: 10
12
2012: 74
13
2013: 164
14
2014: 264
15
2015: 689
16
2016: 482
17
2017: 483
18
2018: 434
19
2019: 311
20
2020: 199
21
2021: 328
22
2022: 204
23
2023: 231
24
2024: 368
25
2025: 518
26
2026: 97

Related Entities for Ophthalmic Femtosecond Laser

Event Locations

I 2,609 (53.7%)
2,152 (44.3%)
HOSPITAL 28 (0.6%)
OTHER 28 (0.6%)
NO INFORMATION 21 (0.4%)
AMBULATORY SURGICAL FACILITY 11 (0.2%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)

Compare WAVELIGHT GMBH vs ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ophthalmic Femtosecond Laser, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Ophthalmic Femtosecond Laser 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 Ophthalmic Femtosecond Laser; 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.