2026 data FDA MAUDE openFDA FDA Class III

Lens, Intraocular, Phakic

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 MAUDE casebook

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

#134 of 1000 · 21,997 reports · 2005–2026

  • BOOK 21,997 reports
  • RANK #134 of 1000
  • DEATH 2 death-typed
  • INJ 17,684 injury-typed
  • MALF 4,234 malfunction
  • SPAN 2005–2026
  • PEAK 2024: 2,147
  • PHOTO Port & Catheter

Nearest event-volume peer: Port & Catheter, Implanted, Subcutaneous, Intravascular (54 report gap)

Lens, Intraocular, Phakic sits #134 of 1000 among tracked device types with 21,997 MAUDE reports spanning 2005–2026. 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, Phakic carries 80.4% INJURY-coded reports, 50.1pp 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 80.4% corpus 30.3% · above corpus mean (+50.1 pp)
  • MALF 19.2% corpus 64.8% · below corpus mean (-45.6 pp)

Lead product-problem code Inadequacy of Device Shape and/or Size is 37% of coded problems · Lead manufacturer STAAR SURGICAL COMPANY accounts for 93% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Lens, Intraocular, Phakic in the event-volume neighbourhood

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

reports

What this shows Lens, Intraocular, Phakic carries 21,997 MAUDE reports, ranked #134 of 1000.

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

Event Types

Injury 17,684 (80.4%)
Malfunction 4,234 (19.2%)
Other 70 (0.3%)
7 (0.0%)
Death 2 (0.0%)

Patient Outcomes

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

Required Intervention 16,594 (74.9%)
4,557 (20.6%)
Other 772 (3.5%)
R 156 (0.7%)
O 23 (0.1%)
Disability 18 (0.1%)
S 16 (0.1%)
Hospitalization 9 (0.0%)
Congenital Anomaly 6 (0.0%)
Life Threatening 3 (0.0%)
C 2 (0.0%)
Death 2 (0.0%)
H 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Inadequacy of Device Shape and/or Size 10,648
Adverse Event Without Identified Device or Use Problem 3,624
Appropriate Device Problem Term/Code Not Available 2,597
Off-Label Use 2,574
No Apparent Adverse Event 1,884
Device Operates Differently Than Expected 1,184
Explanted 1,069
Misfocusing 991
Lens, vaulting 944
Device Dislodged or Dislocated 470
Unintended Movement 442
Insufficient Device Problem Information 395
Optical Problem 343
Torn Material 332
Device remains implanted 247
Other (for use when an appropriate device code cannot be identified) 215
Patient-Device Incompatibility 179
Unknown (for use when the device problem is not known) 123
Lens (IOL), torn, split, cracked 112
Break 90

Yearly Trend

05
2005: 1
07
2007: 4
08
2008: 226
09
2009: 601
10
2010: 551
11
2011: 311
12
2012: 500
13
2013: 696
14
2014: 781
15
2015: 1,279
16
2016: 1,456
17
2017: 1,796
18
2018: 1,778
19
2019: 1,236
20
2020: 1,440
21
2021: 2,063
22
2022: 1,917
23
2023: 2,076
24
2024: 2,147
25
2025: 659
26
2026: 479

Reports fell to 659 in 2025, down from an average of 2,112 in the two years before.

Related Entities for Lens, Intraocular, Phakic

Event Locations

11,897 (54.1%)
I 10,073 (45.8%)
NO INFORMATION 23 (0.1%)
HOME 1 (0.0%)
HOSPITAL 1 (0.0%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare STAAR SURGICAL COMPANY vs STAAR SURGICAL CO. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Lens, Intraocular, Phakic: 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 (21,997 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Lens, Intraocular, Phakic 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, Phakic; 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.