2026 data FDA MAUDE openFDA

Extended Depth Of Focus Intraocular Lens

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 Extended Depth Of Focus Intraocular Lens LIGHT-BOOK · MAUDE

#291 of 1000 · 5,658 reports · 2016–2026

  • BOOK 5,658 reports
  • RANK #291 of 1000
  • DEATH 0 death-typed
  • INJ 4,611 injury-typed
  • MALF 1,047 malfunction
  • SPAN 2016–2026
  • PEAK 2018: 799
  • PHOTO Blade

Nearest event-volume peer: Blade, Saw, General & Plastic Surgery, Surgical (25 report gap)

Extended Depth Of Focus Intraocular Lens sits #291 of 1000 among tracked device types with 5,658 MAUDE reports spanning 2016–2026. 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 81.5% corpus 30.4% · above corpus mean (+51.1 pp)
  • MALF 18.5% corpus 64.5% · below corpus mean (-46.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 68% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HUNTINGTON accounts for 35% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Extended Depth Of Focus Intraocular Lens in the event-volume neighbourhood

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

reports

What this shows Extended Depth Of Focus Intraocular Lens carries 5,658 MAUDE reports, ranked #291 of 1000.

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

Event Types

Injury 4,611 (81.5%)
Malfunction 1,047 (18.5%)

Patient Outcomes

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

Required Intervention 3,746 (64.1%)
1,030 (17.6%)
Other 860 (14.7%)
R 116 (2.0%)
O 77 (1.3%)
S 5 (0.1%)
Hospitalization 5 (0.1%)
Disability 4 (0.1%)
H 3 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,772
Scratched Material 331
Inadequacy of Device Shape and/or Size 180
Break 172
Unintended Movement 162
Appropriate Term/Code Not Available 160
Device Dislodged or Dislocated 158
Defective Device 104
Crack 72
Device Contamination with Chemical or Other Material 67
Material Split, Cut or Torn 63
Material Opacification 42
Malposition of Device 39
Unstable 37
Material Twisted/Bent 31
Product Quality Problem 31
Insufficient Information 29
Failure to Deliver 25
Defective Component 24
Failure to Eject 24

Yearly Trend

16
2016: 110
17
2017: 754
18
2018: 799
19
2019: 735
20
2020: 347
21
2021: 598
22
2022: 635
23
2023: 551
24
2024: 578
25
2025: 501
26
2026: 50

Related Entities for Extended Depth Of Focus Intraocular Lens

Compare ALCON RESEARCH, LLC - HUNTINGTON vs JOHNSON & JOHNSON SURGICAL VISION, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Extended Depth Of Focus Intraocular Lens, 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 (5,658 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Extended Depth Of Focus Intraocular Lens 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 Extended Depth Of Focus Intraocular Lens; 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.