2026 data FDA MAUDE openFDA FDA Class III

Lens, Multifocal 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.

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

FDA MAUDE casebook

openFDA event book Lens, Multifocal Intraocular MID-BOOK · MAUDE

#179 of 1000 · 14,298 reports · 1997–2026

  • BOOK 14,298 reports
  • RANK #179 of 1000
  • DEATH 0 death-typed
  • INJ 10,887 injury-typed
  • MALF 2,402 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 1,311
  • PHOTO Set

Nearest event-volume peer: Set, I.V. Fluid Transfer (33 report gap)

Lens, Multifocal Intraocular sits #179 of 1000 among tracked device types with 14,298 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 →

Malfunction reports sit below the device-type norm

Lens, Multifocal Intraocular carries 16.8% MALFUNCTION-coded reports, 48.0pp below 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 76.1% corpus 30.3% · above corpus mean (+45.9 pp)
  • MALF 16.8% corpus 64.8% · below corpus mean (-48.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 52% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HUNTINGTON accounts for 39% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Lens, Multifocal Intraocular in the event-volume neighbourhood

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

reports

What this shows Lens, Multifocal Intraocular carries 14,298 MAUDE reports, ranked #179 of 1000.

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

Event Types

Injury 10,887 (76.1%)
Malfunction 2,402 (16.8%)
Other 1,003 (7.0%)
6 (0.0%)

Patient Outcomes

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

Required Intervention 8,637 (58.0%)
Other 3,179 (21.3%)
2,325 (15.6%)
R 504 (3.4%)
O 155 (1.0%)
Hospitalization 48 (0.3%)
Disability 23 (0.2%)
S 17 (0.1%)
H 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 7,141
Insufficient Device Problem Information 1,127
Device remains implanted 758
Appropriate Device Problem Term/Code Not Available 733
Scratched Material 700
Break 686
Lens replacement 312
Device Operates Differently Than Expected 292
Device Dislodged or Dislocated 288
Patient-Device Incompatibility 227
Defective Device 200
Crack 179
Material Opacification 156
Malposition of Device 139
Explanted 136
Material Split, Cut or Torn 120
Device Contamination with Chemical or Other Material 108
Use of Device Problem 107
Inadequacy of Device Shape and/or Size 104
Device Difficult to Setup or Prepare 98

Yearly Trend

97
1997: 1
98
1998: 10
99
1999: 14
00
2000: 9
01
2001: 10
02
2002: 3
03
2003: 11
04
2004: 3
05
2005: 1
07
2007: 35
08
2008: 420
09
2009: 586
10
2010: 601
11
2011: 584
12
2012: 308
13
2013: 296
14
2014: 308
15
2015: 708
16
2016: 731
17
2017: 613
18
2018: 629
19
2019: 683
20
2020: 912
21
2021: 1,205
22
2022: 1,265
23
2023: 1,047
24
2024: 1,095
25
2025: 1,311
26
2026: 899

Reports in 2025 (1,311) held close to the prior two-year average of 1,071.

Related Entities for Lens, Multifocal Intraocular

Event Locations

8,967 (62.7%)
I 4,913 (34.4%)
AMBULATORY SURGICAL FACILITY 350 (2.4%)
HOSPITAL 28 (0.2%)
NO INFORMATION 23 (0.2%)
OUTPATIENT TREATMENT FACILITY 7 (0.0%)
UNKNOWN 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
HOME 1 (0.0%)
OTHER 1 (0.0%)

Compare ALCON RESEARCH, LLC - HUNTINGTON vs ABBOTT MEDICAL OPTICS →

Nationwide devices with a comparable report-volume footprint

Lens, Multifocal Intraocular 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.

Disclaimer: MAUDE figures for Lens, Multifocal 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, Multifocal 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.