ALCON RESEARCH, LLC - HOUSTON

FDA MAUDE device safety record · 2018–2026

What the Data Shows About ALCON RESEARCH, LLC - HOUSTON

ALCON RESEARCH, LLC - HOUSTON is associated with 14,642 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2018 through 2026. Of the total, 0 are coded as death reports and 827 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 9 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ALCON RESEARCH, LLC - HOUSTON should be reviewed at the device-family level rather than company-wide. Across those devices, 2 distinct event types appear in the record, led by Malfunction at 13,815 reports (94.4% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 9 years of MAUDE data, with the peak single-year volume reaching 5,798 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

14,642
Total Reports
0
Death Reports
827
Injury Reports
9
Device Types

Event Types

Malfunction 13,815 (94.4%)
Injury 827 (5.6%)

Patient Outcomes

13,733 (92.3%)
Other 451 (3.0%)
Required Intervention 349 (2.3%)
O 151 (1.0%)
R 151 (1.0%)
Hospitalization 21 (0.1%)
H 20 (0.1%)
Disability 4 (0.0%)
S 2 (0.0%)

Yearly Trend

18
2018: 5
19
2019: 193
20
2020: 707
21
2021: 837
22
2022: 1,042
23
2023: 1,905
24
2024: 3,024
25
2025: 5,798
26
2026: 1,131

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 manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.