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2026 data FDA MAUDE openFDA

Folders And Injectors, Intraocular Lens (Iol)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Folders And Injectors, Intraocular Lens LIGHT-BOOK · MAUDE

#305 of 1000 · 5,129 reports · 1997–2026

  • BOOK 5,129 reports
  • RANK #305 of 1000
  • DEATH 0 death-typed
  • INJ 1,979 injury-typed
  • MALF 3,127 malfunction
  • SPAN 1997–2026
  • PEAK 2022: 490
  • PHOTO Compressor

Nearest event-volume peer: Compressor, Air, Portable (15 report gap)

Folders And Injectors, Intraocular Lens (Iol) sits #305 of 1000 among tracked device types with 5,129 MAUDE reports spanning 1997–2026. 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 38.6% corpus 30.4% · above corpus mean (+8.1 pp)
  • MALF 61.0% corpus 64.5% · below corpus mean (-3.5 pp)

Lead product-problem code Device Damaged by Another Device is 22% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HUNTINGTON accounts for 41% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Folders And Injectors, Intraocular Lens in the event-volume neighbourhood

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

reports

What this shows Folders And Injectors, Intraocular Lens (Iol) carries 5,129 MAUDE reports, ranked #305 of 1000.

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

Event Types

Malfunction 3,127 (61.0%)
Injury 1,979 (38.6%)
12 (0.2%)
Other 11 (0.2%)

Patient Outcomes

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

2,855 (55.2%)
Required Intervention 1,265 (24.5%)
Other 984 (19.0%)
R 34 (0.7%)
O 14 (0.3%)
Hospitalization 6 (0.1%)
H 3 (0.1%)
Disability 3 (0.1%)
S 2 (0.0%)
Death 2 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Device Damaged by Another Device 713
Adverse Event Without Identified Device or Use Problem 443
Device Contamination with Chemical or Other Material 405
Crack 389
Scratched Material 249
Material Split, Cut or Torn 204
Break 194
Material Twisted/Bent 87
Defective Device 80
Failure to Eject 77
Contamination /Decontamination Problem 76
Defective Component 70
Split 61
Insufficient Information 53
Difficult to Advance 51
Physical Resistance/Sticking 48
Contamination 38
Inaccurate Delivery 26
Torn Material 26
No Apparent Adverse Event 24

Yearly Trend

97
1997: 2
98
1998: 1
99
1999: 7
00
2000: 15
01
2001: 13
02
2002: 8
04
2004: 31
05
2005: 16
06
2006: 135
07
2007: 445
08
2008: 185
09
2009: 186
10
2010: 203
11
2011: 95
12
2012: 129
13
2013: 203
14
2014: 114
15
2015: 127
16
2016: 112
17
2017: 114
18
2018: 340
19
2019: 271
20
2020: 362
21
2021: 289
22
2022: 490
23
2023: 330
24
2024: 375
25
2025: 437
26
2026: 94

Related Entities for Folders And Injectors, Intraocular Lens (Iol)

Top Manufacturers

ALCON RESEARCH, LLC - HUNTINGTON 1,877
BAUSCH + LOMB 677
BAUSCH & LOMB 671
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 381
ALCON RESEARCH, LTD. - HUNTINGTON 355
STAAR SURGICAL CO. 354
STAAR SURGICAL COMPANY 170
BAUSCH & LOMB, INC. 138

Event Locations

3,575 (69.7%)
I 1,479 (28.8%)
HOSPITAL 34 (0.7%)
AMBULATORY SURGICAL FACILITY 17 (0.3%)
NO INFORMATION 11 (0.2%)
UNKNOWN 8 (0.2%)
OTHER 4 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ALCON RESEARCH, LLC - HUNTINGTON vs BAUSCH + LOMB →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Folders And Injectors, 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 (5,129 here).

Compressor, Air, Portable 5,114 Temporary Carotid Catheter For Embolic Capt… 5,148 System, X-Ray, Tomography, Computed 5,150 Anesthesia Conduction Kit 5,092

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Folders And Injectors, 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 Folders And Injectors, 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.