2026 data FDA MAUDE openFDA FDA Class III

Lens, Intraocular, Toric Optics

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 Lens, Intraocular, Toric Optics LIGHT-BOOK · MAUDE

#246 of 1000 · 7,999 reports · 2008–2026

  • BOOK 7,999 reports
  • RANK #246 of 1000
  • DEATH 0 death-typed
  • INJ 4,382 injury-typed
  • MALF 3,327 malfunction
  • SPAN 2008–2026
  • PEAK 2025: 1,762
  • PHOTO Set

Nearest event-volume peer: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (12 report gap)

Lens, Intraocular, Toric Optics sits #246 of 1000 among tracked device types with 7,999 MAUDE reports spanning 2008–2026. 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

Lens, Intraocular, Toric Optics carries 54.8% INJURY-coded reports, 24.5pp 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 54.8% corpus 30.3% · above corpus mean (+24.5 pp)
  • MALF 41.6% corpus 64.8% · below corpus mean (-23.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer ALCON LABORATORIES IRELAND LTD. accounts for 35% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Lens, Intraocular, Toric Optics in the event-volume neighbourhood

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

reports

What this shows Lens, Intraocular, Toric Optics carries 7,999 MAUDE reports, ranked #246 of 1000.

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

Event Types

Injury 4,382 (54.8%)
Malfunction 3,327 (41.6%)
Other 289 (3.6%)
1 (0.0%)

Patient Outcomes

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

Required Intervention 3,254 (38.7%)
3,225 (38.3%)
Other 1,448 (17.2%)
R 347 (4.1%)
O 97 (1.2%)
Hospitalization 27 (0.3%)
S 7 (0.1%)
Disability 4 (0.0%)
H 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,336
Break 689
Scratched Material 623
Device Dislodged or Dislocated 481
Insufficient Device Problem Information 376
Material Discolored 277
Device remains implanted 260
Device Difficult to Setup or Prepare 221
Defective Device 216
Appropriate Device Problem Term/Code Not Available 212
Device Operates Differently Than Expected 197
Failure to Deliver 192
Material Split, Cut or Torn 176
Malposition of Device 169
Crack 167
Material Twisted/Bent 159
Unstable 130
Failure to Advance 114
Product Quality Problem 98
Device Damaged by Another Device 87

Yearly Trend

08
2008: 87
09
2009: 259
10
2010: 162
11
2011: 1
12
2012: 6
13
2013: 7
14
2014: 86
15
2015: 389
16
2016: 285
17
2017: 311
18
2018: 364
19
2019: 382
20
2020: 211
21
2021: 285
22
2022: 513
23
2023: 748
24
2024: 1,155
25
2025: 1,762
26
2026: 986

Reports rose to 1,762 in 2025, up from an average of 952 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Lens, Intraocular, Toric Optics

Compare ALCON LABORATORIES IRELAND LTD. vs ALCON RESEARCH, LLC - HUNTINGTON →

Nationwide devices with a comparable report-volume footprint

Lens, Intraocular, Toric Optics 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 (7,999 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 Lens, Intraocular, Toric Optics 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 Lens, Intraocular, Toric Optics; 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.