2026 data FDA MAUDE openFDA FDA Class III

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 Class III (highest risk, premarket approval required), regulated under 21 CFR §886.3600 (Ophthalmic panel).

FDA MAUDE casebook

openFDA event book Extended Depth Of Focus Intraocular Lens LIGHT-BOOK · MAUDE

#296 of 1000 · 5,816 reports · 2016–2026

  • BOOK 5,816 reports
  • RANK #296 of 1000
  • DEATH 0 death-typed
  • INJ 4,688 injury-typed
  • MALF 1,128 malfunction
  • SPAN 2016–2026
  • PEAK 2018: 799
  • PHOTO Holder

Nearest event-volume peer: Holder, Head, Neurosurgical (Skull Clamp) (10 report gap)

Extended Depth Of Focus Intraocular Lens sits #296 of 1000 among tracked device types with 5,816 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 →

Injury-coded reports run above the device-type norm

Extended Depth Of Focus Intraocular Lens carries 80.6% INJURY-coded reports, 50.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 80.6% corpus 30.3% · above corpus mean (+50.3 pp)
  • MALF 19.4% corpus 64.8% · below corpus mean (-45.4 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 36% of manufacturer-tagged reports · Top event location I is 54% 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 5,816 MAUDE reports, ranked #296 of 1000.

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

Event Types

Injury 4,688 (80.6%)
Malfunction 1,128 (19.4%)

Patient Outcomes

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

Required Intervention 3,808 (63.4%)
1,112 (18.5%)
Other 873 (14.5%)
R 119 (2.0%)
O 80 (1.3%)
S 5 (0.1%)
Hospitalization 5 (0.1%)
Disability 4 (0.1%)
H 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,837
Scratched Material 347
Break 183
Inadequacy of Device Shape and/or Size 180
Device Dislodged or Dislocated 162
Unintended Movement 162
Appropriate Device Problem Term/Code Not Available 160
Defective Device 104
Crack 72
Material Split, Cut or Torn 68
Device Contamination with Chemical or Other Material 67
Material Opacification 44
Product Quality Problem 41
Malposition of Device 39
Material Twisted/Bent 39
Failure to Deliver 37
Unstable 37
Insufficient Device Problem Information 30
Device Difficult to Setup or Prepare 29
Device Damaged by Another Device 27

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: 208

Reports in 2025 (501) held close to the prior two-year average of 565.

Related Entities for Extended Depth Of Focus Intraocular Lens

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

Nationwide devices with a comparable report-volume footprint

Extended Depth Of Focus Intraocular Lens 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 (5,816 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.