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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Intraocular Lens MID-BOOK · MAUDE

#46 of 1000 · 77,018 reports · 1992–2026

  • BOOK 77,018 reports
  • RANK #46 of 1000
  • DEATH 4 death-typed
  • INJ 33,504 injury-typed
  • MALF 40,019 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 5,388
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (272 report gap)

Intraocular Lens sits #46 of 1000 among tracked device types with 77,018 MAUDE reports spanning 1992–2026. 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 43.5% corpus 30.4% · above corpus mean (+13.1 pp)
  • MALF 52.0% corpus 64.5% · below corpus mean (-12.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer AMO PUERTO RICO MFG. INC. accounts for 16% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Intraocular Lens in the event-volume neighbourhood

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

reports

What this shows Intraocular Lens carries 77,018 MAUDE reports, ranked #46 of 1000.

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

Event Types

Malfunction 40,019 (52.0%)
Injury 33,504 (43.5%)
Other 3,288 (4.3%)
203 (0.3%)
Death 4 (0.0%)

Patient Outcomes

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

39,138 (50.0%)
Required Intervention 26,105 (33.3%)
Other 11,261 (14.4%)
R 996 (1.3%)
Disability 221 (0.3%)
Hospitalization 221 (0.3%)
O 171 (0.2%)
S 134 (0.2%)
H 17 (0.0%)
Death 8 (0.0%)
Life Threatening 6 (0.0%)
Congenital Anomaly 5 (0.0%)
Invalid Data 4 (0.0%)
L 3 (0.0%)
D 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 6,259
Break 6,118
Scratched Material 2,608
Material Split, Cut or Torn 1,507
Crack 1,501
Defective Device 936
Failure to Eject 889
Appropriate Term/Code Not Available 791
Device Difficult to Setup or Prepare 727
Material Opacification 719
Device Contamination with Chemical or Other Material 716
Material Twisted/Bent 699
Contamination 683
Failure to Advance 674
Device Dislodged or Dislocated 627
Material Fragmentation 592
Insufficient Information 569
Use of Device Problem 514
Device Damaged by Another Device 489
Device Operates Differently Than Expected 470

Yearly Trend

92
1992: 39
93
1993: 50
94
1994: 50
95
1995: 60
96
1996: 209
97
1997: 352
98
1998: 1,693
99
1999: 2,070
00
2000: 1,243
01
2001: 1,139
02
2002: 1,224
03
2003: 1,569
04
2004: 2,745
05
2005: 2,070
06
2006: 3,727
07
2007: 3,640
08
2008: 3,137
09
2009: 1,862
10
2010: 2,172
11
2011: 2,672
12
2012: 2,802
13
2013: 2,555
14
2014: 2,650
15
2015: 4,673
16
2016: 2,214
17
2017: 2,386
18
2018: 2,501
19
2019: 3,086
20
2020: 1,981
21
2021: 2,925
22
2022: 3,290
23
2023: 3,906
24
2024: 4,162
25
2025: 5,388
26
2026: 776

Related Entities for Intraocular Lens

Top Manufacturers

AMO PUERTO RICO MFG. INC. 8,413
STAAR SURGICAL CO. 6,999
ABBOTT MEDICAL OPTICS 6,038
ALCON RESEARCH, LLC - HUNTINGTON 5,874
BAUSCH & LOMB 5,773
ALCON LABORATORIES IRELAND LTD. 4,743
STAAR SURGICAL COMPANY 4,576
JOHNSON & JOHNSON SURGICAL VISION, INC. 3,398
ALCON LABORATORIES, INC. 3,380
ALCON RESEARCH, LTD. / HUNTINGTON 2,803

Event Locations

52,687 (68.4%)
I 16,500 (21.4%)
HOSPITAL 3,282 (4.3%)
AMBULATORY SURGICAL FACILITY 1,837 (2.4%)
NO INFORMATION 795 (1.0%)
UNKNOWN 792 (1.0%)
NOT APPLICABLE 413 (0.5%)
OUTPATIENT TREATMENT FACILITY 269 (0.3%)
OTHER 176 (0.2%)
INVALID DATA 163 (0.2%)
HOME 50 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 49 (0.1%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
NURSING HOME 2 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare AMO PUERTO RICO MFG. INC. vs STAAR SURGICAL CO. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for 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 (77,018 here).

Analyzer, Chemistry, For Clinical Use 76,746 Orthopedic Manual Surgical Instrument 78,848 Transcervical Contraceptive Tubal Occlusion… 74,358 Stimulator 79,738

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for 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 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.