ALCON RESEARCH, LLC - ALCON PRECISION DEVICE

FDA MAUDE device safety record · 2018–2026

What the Data Shows About ALCON RESEARCH, LLC - ALCON PRECISION DEVICE

ALCON RESEARCH, LLC - ALCON PRECISION DEVICE is associated with 6,383 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 582 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 18 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 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 5,801 reports (90.9% 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 2,400 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.

6,383
Total Reports
0
Death Reports
582
Injury Reports
18
Device Types

Event Types

Malfunction 5,801 (90.9%)
Injury 582 (9.1%)

Patient Outcomes

5,772 (88.1%)
Other 350 (5.3%)
Required Intervention 222 (3.4%)
O 98 (1.5%)
R 86 (1.3%)
Hospitalization 14 (0.2%)
H 9 (0.1%)
Disability 2 (0.0%)
S 1 (0.0%)

Yearly Trend

18
2018: 47
19
2019: 453
20
2020: 323
21
2021: 474
22
2022: 462
23
2023: 724
24
2024: 2,400
25
2025: 1,297
26
2026: 203

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.