ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER

FDA MAUDE device safety record · 2015–2026

What the Data Shows About ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER is associated with 11,809 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2026. Of the total, 0 are coded as death reports and 2,117 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 16 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 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 9,692 reports (82.1% 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 11 years of MAUDE data, with the peak single-year volume reaching 2,095 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.

11,809
Total Reports
0
Death Reports
2,117
Injury Reports
16
Device Types

Event Types

Malfunction 9,692 (82.1%)
Injury 2,117 (17.9%)

Patient Outcomes

9,621 (77.0%)
Other 1,211 (9.7%)
Required Intervention 898 (7.2%)
R 351 (2.8%)
O 350 (2.8%)
Hospitalization 26 (0.2%)
H 19 (0.2%)
Disability 10 (0.1%)
S 2 (0.0%)

Yearly Trend

15
2015: 1
17
2017: 4
18
2018: 166
19
2019: 2,095
20
2020: 1,051
21
2021: 1,418
22
2022: 1,686
23
2023: 1,581
24
2024: 1,828
25
2025: 1,740
26
2026: 239

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.