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 Class II (moderate risk, special controls required), regulated under 21 CFR §886.4390 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Ophthalmic Femtosecond Laser LIGHT-BOOK · MAUDE
#320 of 1000 · 5,003 reports · 2011–2026
- BOOK 5,003 reports
- RANK #320 of 1000
- DEATH 0 death-typed
- INJ 2,893 injury-typed
- MALF 2,026 malfunction
- SPAN 2011–2026
- PEAK 2015: 689
- PHOTO Tape And Bandage
Nearest event-volume peer: Tape And Bandage, Adhesive (20 report gap)
Ophthalmic Femtosecond Laser sits #320 of 1000 among tracked device types with 5,003 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 →
Injury-coded reports run above the device-type norm
Ophthalmic Femtosecond Laser carries 57.8% INJURY-coded reports, 27.5pp 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 57.8% corpus 30.3% · above corpus mean (+27.5 pp)
- MALF 40.5% corpus 64.8% · below corpus mean (-24.3 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer WAVELIGHT GMBH accounts for 40% of manufacturer-tagged reports · Top event location I is 52% of location-tagged rows .
Ophthalmic Femtosecond Laser in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Nerve
5,083 reports
- Accessories
Accessories, Cleaning, For Endoscope
5,046 reports
- Monitor
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
5,034 reports
- Ophthalmic Fe… (this)
Ophthalmic Femtosecond Laser
5,003 reports
- Tape And Band…
Tape And Bandage, Adhesive
4,983 reports
- Accessories
Accessories, Implant, Dental, Endosseous
4,902 reports
What this shows Ophthalmic Femtosecond Laser carries 5,003 MAUDE reports, ranked #320 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 518 in 2025, up from an average of 300 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Ophthalmic Femtosecond Laser
Top Manufacturers
Event Locations
Compare WAVELIGHT GMBH vs ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER →
Nationwide devices with a comparable report-volume footprint
Ophthalmic Femtosecond Laser 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 (5,003 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.