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Lens, Contact, (Disposable)

Open-data reference.

FDA MAUDE adverse event data · 1998–2026

What the Data Shows About Lens, Contact, (Disposable)

The FDA MAUDE database aggregates 363 adverse-event reports for Lens, Contact, (Disposable) spanning the period from 1998 through 2026. Of these, 0 are classified as death reports, 354 as injury reports, and 5 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 3 distinct event types and 10 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 150 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 20 years of MAUDE data, with the peak single-year volume reaching 35 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 5 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

363
Total Reports
0
Death Reports
354
Injury Reports
5
Malfunctions

Event Types

Injury 354 (97.5%)
Malfunction 5 (1.4%)
4 (1.1%)

Patient Outcomes

Other 269 (63.0%)
Required Intervention 62 (14.5%)
R 31 (7.3%)
O 24 (5.6%)
Hospitalization 13 (3.0%)
11 (2.6%)
Disability 8 (1.9%)
S 6 (1.4%)
H 2 (0.5%)
L 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 150
Insufficient Information 36
Material Split, Cut or Torn 16
Defective Device 15
Patient-Device Incompatibility 14
Improper or Incorrect Procedure or Method 13
Product Quality Problem 6
Break 4
Device Handling Problem 3
Entrapment of Device 3
Device Contamination with Chemical or Other Material 2
Difficult to Remove 2
Expiration Date Error 2
Fitting Problem 2
Material Fragmentation 2
Material Rupture 2
Material Twisted/Bent 2
No Apparent Adverse Event 2
Tear, Rip or Hole in Device Packaging 2
Torn Material 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: 6

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.