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2026 data FDA MAUDE openFDA FDA Class II

Lens, Contact, (Disposable)

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).

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FDA MAUDE casebook

openFDA event book Lens, Contact, LIGHT-BOOK · MAUDE

#991 of 1000 · 372 reports · 1998–2026

  • BOOK 372 reports
  • RANK #991 of 1000
  • DEATH 0 death-typed
  • INJ 363 injury-typed
  • MALF 5 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 35
  • PHOTO Azo Dye, Calcium

Nearest event-volume peer: Azo Dye, Calcium (0 report gap)

Lens, Contact, (Disposable) sits #991 of 1000 among tracked device types with 372 MAUDE reports spanning 1998–2026. 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, Contact, carries 97.6% INJURY-coded reports, 67.3pp 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 97.6% corpus 30.3% · above corpus mean (+67.3 pp)
  • MALF 1.3% corpus 64.8% · below corpus mean (-63.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 57% of coded problems · Lead manufacturer BAUSCH & LOMB INCORPORATED accounts for 100% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Lens, Contact, in the event-volume neighbourhood

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

reports

What this shows Lens, Contact, (Disposable) carries 372 MAUDE reports, ranked #991 of 1000.

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

Event Types

Injury 363 (97.6%)
Malfunction 5 (1.3%)
4 (1.1%)

Patient Outcomes

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

Other 276 (63.0%)
Required Intervention 64 (14.6%)
R 32 (7.3%)
O 25 (5.7%)
Hospitalization 13 (3.0%)
11 (2.5%)
Disability 8 (1.8%)
S 6 (1.4%)
H 2 (0.5%)
L 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 220
Insufficient Device Problem Information 61
Material Split, Cut or Torn 18
Improper or Incorrect Procedure or Method 15
Defective Device 14
Patient-Device Incompatibility 14
Torn Material 8
Product Quality Problem 6
Break 4
Difficult to Remove 4
No Apparent Adverse Event 4
Device Handling Problem 3
Entrapment of Device 3
Material Fragmentation 3
Component Missing 2
Device Contamination with Chemical or Other Material 2
Expiration Date Error 2
Fitting Problem 2
Material Rupture 2
Material Twisted/Bent 2

Yearly Trend

98
1998: 1
00
2000: 1
01
2001: 1
10
2010: 3
11
2011: 9
12
2012: 25
13
2013: 35
14
2014: 20
15
2015: 10
16
2016: 18
17
2017: 23
18
2018: 32
19
2019: 34
20
2020: 32
21
2021: 24
22
2022: 18
23
2023: 24
24
2024: 25
25
2025: 22
26
2026: 15

Reports in 2025 (22) held close to the prior two-year average of 25.

Related Entities for Lens, Contact, (Disposable)

Top Manufacturers

BAUSCH & LOMB INCORPORATED 32

Event Locations

201 (54.0%)
I 146 (39.2%)
NO INFORMATION 22 (5.9%)
HOME 2 (0.5%)
UNKNOWN 1 (0.3%)

Nationwide devices with a comparable report-volume footprint

Lens, Contact, 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 (372 here).

Azo Dye, Calcium 372 Crutch 373 Multi-Analyte Test System With Algorithmic… 371 Probe, Thermodilution 373

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 Lens, Contact, 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, Contact,; 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.