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2026 data FDA MAUDE openFDA

Lens, Guide, Intraocular

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 Lens, Guide, Intraocular LIGHT-BOOK · MAUDE

#231 of 1000 · 8,539 reports · 1996–2026

  • BOOK 8,539 reports
  • RANK #231 of 1000
  • DEATH 0 death-typed
  • INJ 1,568 injury-typed
  • MALF 6,936 malfunction
  • SPAN 1996–2026
  • PEAK 2001: 1,294
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Continuous Flush (4 report gap)

Lens, Guide, Intraocular sits #231 of 1000 among tracked device types with 8,539 MAUDE reports spanning 1996–2026. 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 18.4% corpus 30.4% · below corpus mean (-12.1 pp)
  • MALF 81.2% corpus 64.5% · above corpus mean (+16.7 pp)

Lead product-problem code Device Damaged by Another Device is 13% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HUNTINGTON accounts for 28% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Lens, Guide, Intraocular in the event-volume neighbourhood

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

reports

What this shows Lens, Guide, Intraocular carries 8,539 MAUDE reports, ranked #231 of 1000.

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

Event Types

Malfunction 6,936 (81.2%)
Injury 1,568 (18.4%)
Other 28 (0.3%)
7 (0.1%)

Patient Outcomes

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

6,478 (74.8%)
Required Intervention 1,147 (13.2%)
Other 886 (10.2%)
R 112 (1.3%)
Hospitalization 19 (0.2%)
O 15 (0.2%)
S 5 (0.1%)
H 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Device Damaged by Another Device 518
Break 498
Crack 360
Failure to Eject 322
Scratched Material 253
Failure to Advance 236
Defective Device 217
Device Contamination with Chemical or Other Material 185
Material Twisted/Bent 175
Contamination 144
Physical Resistance/Sticking 119
Adverse Event Without Identified Device or Use Problem 114
Device Difficult to Setup or Prepare 108
Defective Component 99
Appropriate Term/Code Not Available 97
Difficult to Advance 89
Material Split, Cut or Torn 87
Material Deformation 75
Inaccurate Delivery 74
Positioning Failure 74

Yearly Trend

96
1996: 9
97
1997: 12
98
1998: 5
99
1999: 302
00
2000: 484
01
2001: 1,294
02
2002: 61
03
2003: 52
04
2004: 311
05
2005: 224
06
2006: 301
07
2007: 570
08
2008: 258
09
2009: 73
10
2010: 81
11
2011: 58
12
2012: 125
13
2013: 39
14
2014: 49
15
2015: 160
16
2016: 256
17
2017: 335
18
2018: 592
19
2019: 703
20
2020: 335
21
2021: 349
22
2022: 294
23
2023: 304
24
2024: 416
25
2025: 433
26
2026: 54

Related Entities for Lens, Guide, Intraocular

Top Manufacturers

ALCON RESEARCH, LLC - HUNTINGTON 1,525
STAAR SURGICAL CO. 914
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 718
ALCON RESEARCH, LTD. - HUNTINGTON 603
ABBOTT MEDICAL OPTICS 543
ALCON LABORATORIES, INC. 441
JOHNSON & JOHNSON SURGICAL VISION, INC. 393
STAAR SURGICAL COMPANY 392

Event Locations

3,725 (43.6%)
I 2,584 (30.3%)
HOSPITAL 1,178 (13.8%)
AMBULATORY SURGICAL FACILITY 776 (9.1%)
NO INFORMATION 84 (1.0%)
UNKNOWN 63 (0.7%)
OUTPATIENT TREATMENT FACILITY 44 (0.5%)
OUTPATIENT DIAGNOSTIC FACILITY 35 (0.4%)
NOT APPLICABLE 31 (0.4%)
OTHER 13 (0.2%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
HOME 2 (0.0%)
INVALID DATA 2 (0.0%)

Compare ALCON RESEARCH, LLC - HUNTINGTON vs STAAR SURGICAL CO. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Lens, Guide, Intraocular, 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 (8,539 here).

Catheter, Continuous Flush 8,543 Catheter 8,601 Catheter, Thrombus Retriever 8,409 Dialyzer, Capillary, Hollow Fiber 8,369

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 Lens, Guide, Intraocular 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, Guide, Intraocular; 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.