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2026 data FDA MAUDE openFDA FDA Class III

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

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).

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FDA MAUDE casebook

openFDA event book Light Adjustable Lens And Light Delivery De… LIGHT-BOOK · MAUDE

#593 of 1000 · 1,354 reports · 2020–2026

  • BOOK 1,354 reports
  • RANK #593 of 1000
  • DEATH 0 death-typed
  • INJ 1,349 injury-typed
  • MALF 4 malfunction
  • SPAN 2020–2026
  • PEAK 2025: 447
  • PHOTO Electrode

Nearest event-volume peer: Electrode, Electrocardiograph, Multi-Function (7 report gap)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) sits #593 of 1000 among tracked device types with 1,354 MAUDE reports spanning 2020–2026. 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

Light Adjustable Lens And Light Delivery De… carries 99.6% INJURY-coded reports, 69.3pp 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 99.6% corpus 30.3% · above corpus mean (+69.3 pp)
  • MALF 0.3% corpus 64.8% · below corpus mean (-64.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 62% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 94% of location-tagged rows .

Light Adjustable Lens And Light Delivery De… in the event-volume neighbourhood

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

reports

What this shows Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) carries 1,354 MAUDE reports, ranked #593 of 1000.

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

Event Types

Injury 1,349 (99.6%)
Malfunction 4 (0.3%)
Other 1 (0.1%)

Patient Outcomes

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

Required Intervention 1,078 (81.5%)
Disability 150 (11.3%)
Other 55 (4.2%)
R 15 (1.1%)
S 12 (0.9%)
7 (0.5%)
O 2 (0.2%)
Hospitalization 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 850
Optical Problem 123
Use of Device Problem 93
Optical Decentration 80
Patient-Device Incompatibility 67
Insufficient Device Problem Information 51
Improper or Incorrect Procedure or Method 28
Optical Distortion 24
Device Dislodged or Dislocated 18
Patient Device Interaction Problem 7
Malposition of Device 4
Scratched Material 4
Unintended Movement 4
Detachment of Device or Device Component 3
Material Opacification 3
Product Quality Problem 3
Therapeutic or Diagnostic Output Failure 3
Device Handling Problem 2
Misfocusing 2
Output Problem 2

Yearly Trend

20
2020: 18
21
2021: 88
22
2022: 77
23
2023: 121
24
2024: 260
25
2025: 447
26
2026: 343

Reports rose to 447 in 2025, up from an average of 191 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Top Manufacturers

UNK 1

Event Locations

1,277 (94.3%)
I 76 (5.6%)
NO INFORMATION 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Light Adjustable Lens And Light Delivery De… 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 (1,354 here).

Electrode 1,347 Catheter For Crossing Total Occlusions 1,370 Implant 1,332 Intrauterine Tamponade Balloon 1,328

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 Light Adjustable Lens And Light Delivery De… 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 Light Adjustable Lens And Light Delivery De…; 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.