2026 data FDA MAUDE openFDA FDA Class II

Lenses, Soft Contact, Daily Wear

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 II (moderate risk, special controls required), regulated under 21 CFR §886.5925 (Ophthalmic panel).

FDA MAUDE casebook

openFDA event book Lenses, Soft Contact, Daily Wear LIGHT-BOOK · MAUDE

#325 of 1000 · 4,868 reports · 1994–2026

  • BOOK 4,868 reports
  • RANK #325 of 1000
  • DEATH 0 death-typed
  • INJ 4,422 injury-typed
  • MALF 240 malfunction
  • SPAN 1994–2026
  • PEAK 2011: 377
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Flow Directed (5 report gap)

Lenses, Soft Contact, Daily Wear sits #325 of 1000 among tracked device types with 4,868 MAUDE reports spanning 1994–2026. 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

Lenses, Soft Contact, Daily Wear carries 90.8% INJURY-coded reports, 60.5pp 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 90.8% corpus 30.3% · above corpus mean (+60.5 pp)
  • MALF 4.9% corpus 64.8% · below corpus mean (-59.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 28% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Lenses, Soft Contact, Daily Wear in the event-volume neighbourhood

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

reports

What this shows Lenses, Soft Contact, Daily Wear carries 4,868 MAUDE reports, ranked #325 of 1000.

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

Event Types

Injury 4,422 (90.8%)
Malfunction 240 (4.9%)
Other 135 (2.8%)
71 (1.5%)

Patient Outcomes

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

Other 2,690 (42.2%)
Required Intervention 1,481 (23.2%)
R 996 (15.6%)
336 (5.3%)
O 325 (5.1%)
Hospitalization 192 (3.0%)
S 187 (2.9%)
Disability 151 (2.4%)
H 15 (0.2%)
Life Threatening 4 (0.1%)
L 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,286
Insufficient Device Problem Information 657
Disposable 639
Unknown (for use when the device problem is not known) 602
No Apparent Adverse Event 211
Patient-Device Incompatibility 167
Device Operates Differently Than Expected 144
Improper or Incorrect Procedure or Method 122
Use of Device Problem 119
Nonstandard Device 102
Difficult to Remove 85
Reaction 76
Torn Material 60
Appropriate Device Problem Term/Code Not Available 58
Material Split, Cut or Torn 56
Break 49
Replace 43
Product Quality Problem 36
Other (for use when an appropriate device code cannot be identified) 33
Defective Device 31

Yearly Trend

94
1994: 18
95
1995: 8
96
1996: 26
97
1997: 34
98
1998: 58
99
1999: 33
00
2000: 41
01
2001: 41
02
2002: 57
03
2003: 103
04
2004: 102
05
2005: 108
06
2006: 156
07
2007: 280
08
2008: 214
09
2009: 137
10
2010: 222
11
2011: 377
12
2012: 250
13
2013: 151
14
2014: 179
15
2015: 161
16
2016: 193
17
2017: 280
18
2018: 257
19
2019: 205
20
2020: 117
21
2021: 110
22
2022: 126
23
2023: 178
24
2024: 297
25
2025: 217
26
2026: 132

Reports in 2025 (217) held close to the prior two-year average of 238.

Related Entities for Lenses, Soft Contact, Daily Wear

Top Manufacturers

UNK 121

Event Locations

3,205 (65.8%)
I 975 (20.0%)
NO INFORMATION 246 (5.1%)
UNKNOWN 232 (4.8%)
HOME 141 (2.9%)
INVALID DATA 23 (0.5%)
OTHER 16 (0.3%)
HOSPITAL 11 (0.2%)
NOT APPLICABLE 7 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.1%)
PUBLIC VENUE 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
NURSING HOME 1 (0.0%)
OUTDOORS 1 (0.0%)

Nationwide devices with a comparable report-volume footprint

Lenses, Soft Contact, Daily Wear 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 (4,868 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 Lenses, Soft Contact, Daily Wear 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 Lenses, Soft Contact, Daily Wear; 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.