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2026 data FDA MAUDE openFDA FDA Class III

Phakic Toric Intraocular Lens

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 Phakic Toric Intraocular Lens MID-BOOK · MAUDE

#150 of 1000 · 18,233 reports · 2015–2026

  • BOOK 18,233 reports
  • RANK #150 of 1000
  • DEATH 1 death-typed
  • INJ 15,182 injury-typed
  • MALF 3,050 malfunction
  • SPAN 2015–2026
  • PEAK 2023: 3,703
  • PHOTO Motor

Nearest event-volume peer: Motor, Surgical Instrument, Ac-Powered (39 report gap)

Phakic Toric Intraocular Lens sits #150 of 1000 among tracked device types with 18,233 MAUDE reports spanning 2015–2026. 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

Phakic Toric Intraocular Lens carries 83.3% INJURY-coded reports, 53.0pp 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 83.3% corpus 30.3% · above corpus mean (+53.0 pp)
  • MALF 16.7% corpus 64.8% · below corpus mean (-48.1 pp)

Lead product-problem code Inadequacy of Device Shape and/or Size is 37% of coded problems · Lead manufacturer STAAR SURGICAL COMPANY accounts for 100% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Phakic Toric Intraocular Lens in the event-volume neighbourhood

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

reports

What this shows Phakic Toric Intraocular Lens carries 18,233 MAUDE reports, ranked #150 of 1000.

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

Event Types

Injury 15,182 (83.3%)
Malfunction 3,050 (16.7%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 14,779 (80.6%)
3,002 (16.4%)
Other 402 (2.2%)
R 78 (0.4%)
O 20 (0.1%)
S 18 (0.1%)
Congenital Anomaly 10 (0.1%)
Disability 7 (0.0%)
Hospitalization 5 (0.0%)
C 4 (0.0%)
H 4 (0.0%)
Life Threatening 4 (0.0%)
L 1 (0.0%)

Top Product Problems

Inadequacy of Device Shape and/or Size 8,699
Adverse Event Without Identified Device or Use Problem 5,573
Off-Label Use 3,351
No Apparent Adverse Event 1,869
Device Dislodged or Dislocated 1,618
Misfocusing 1,401
Optical Problem 273
Unintended Movement 193
Patient-Device Incompatibility 182
Improper or Incorrect Procedure or Method 65
Appropriate Device Problem Term/Code Not Available 17
Patient Device Interaction Problem 14
Insufficient Device Problem Information 10
Ejection Problem 9
Difficult to Fold, Unfold or Collapse 7
Particulates 6
Material Integrity Problem 5
Material Opacification 5
Product Quality Problem 4
Material Split, Cut or Torn 3

Yearly Trend

15
2015: 3
16
2016: 1
17
2017: 19
18
2018: 10
19
2019: 1,102
20
2020: 1,757
21
2021: 2,887
22
2022: 2,795
23
2023: 3,703
24
2024: 3,606
25
2025: 1,397
26
2026: 953

Reports fell to 1,397 in 2025, down from an average of 3,655 in the two years before.

Related Entities for Phakic Toric Intraocular Lens

Top Manufacturers

STAAR SURGICAL COMPANY 17,366
STAAR Surgical Company 51

Event Locations

13,357 (73.3%)
I 4,875 (26.7%)
HOSPITAL 1 (0.0%)

Compare STAAR SURGICAL COMPANY vs STAAR Surgical Company →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Phakic Toric Intraocular Lens: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (18,233 here).

Motor, Surgical Instrument, Ac-Powered 18,194 Device, Incontinence, Mechanical/Hydraulic 18,299 Immunoassay Method, Troponin Subunit 18,095 Humidifier, Respiratory Gas, 18,072

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Phakic Toric 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 Phakic Toric 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.