2026 data FDA MAUDE openFDA FDA Class III

Lens, Intraocular, Accommodative

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, Accommodative LIGHT-BOOK · MAUDE

#588 of 1000 · 1,402 reports · 2004–2026

  • BOOK 1,402 reports
  • RANK #588 of 1000
  • DEATH 0 death-typed
  • INJ 1,382 injury-typed
  • MALF 15 malfunction
  • SPAN 2004–2026
  • PEAK 2014: 267
  • PHOTO Sacroiliac Joint Fixa…

Nearest event-volume peer: Sacroiliac Joint Fixation (4 report gap)

Lens, Intraocular, Accommodative sits #588 of 1000 among tracked device types with 1,402 MAUDE reports spanning 2004–2026. 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, Accommodative carries 98.6% INJURY-coded reports, 68.3pp 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 98.6% corpus 30.3% · above corpus mean (+68.3 pp)
  • MALF 1.1% corpus 64.8% · below corpus mean (-63.8 pp)

Lead product-problem code Device Dislodged or Dislocated is 46% of coded problems · Lead manufacturer BAUSCH + LOMB accounts for 78% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Lens, Intraocular, Accommodative in the event-volume neighbourhood

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

reports

What this shows Lens, Intraocular, Accommodative carries 1,402 MAUDE reports, ranked #588 of 1000.

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

Event Types

Injury 1,382 (98.6%)
Malfunction 15 (1.1%)
3 (0.2%)
Other 2 (0.1%)

Patient Outcomes

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

Other 1,031 (73.1%)
Required Intervention 323 (22.9%)
41 (2.9%)
Disability 6 (0.4%)
R 5 (0.4%)
S 2 (0.1%)
O 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Device Dislodged or Dislocated 655
Adverse Event Without Identified Device or Use Problem 352
Malposition of Device 116
Break 54
Insufficient Device Problem Information 39
Explanted 27
Device remains implanted 23
Torn Material 21
Positioning Problem 16
Material Twisted/Bent 14
Difficult To Position 11
Lens, vaulting 11
Appropriate Device Problem Term/Code Not Available 10
Bent 10
Device Operates Differently Than Expected 10
Lens replacement 10
Device Damaged by Another Device 9
Replace 8
Use of Device Problem 8
Optical Decentration 6

Yearly Trend

04
2004: 17
05
2005: 18
06
2006: 7
07
2007: 7
09
2009: 4
10
2010: 139
11
2011: 146
12
2012: 78
13
2013: 130
14
2014: 267
15
2015: 238
16
2016: 147
17
2017: 68
18
2018: 49
19
2019: 34
20
2020: 23
21
2021: 18
22
2022: 8
23
2023: 2
24
2024: 1
26
2026: 1

Reports fell to 1 in 2024, down from an average of 5 in the two years before.

Related Entities for Lens, Intraocular, Accommodative

Event Locations

949 (67.7%)
I 439 (31.3%)
NO INFORMATION 9 (0.6%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
HOSPITAL 2 (0.1%)
OTHER 1 (0.1%)

Compare BAUSCH + LOMB vs BAUSCH & LOMB →

Nationwide devices with a comparable report-volume footprint

Lens, Intraocular, Accommodative 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 (1,402 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, Accommodative 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, Accommodative; 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.