ALCON RESEARCH, LTD. - HUNTINGTON

FDA MAUDE device safety record · 2011–2019

What the Data Shows About ALCON RESEARCH, LTD. - HUNTINGTON

ALCON RESEARCH, LTD. - HUNTINGTON is associated with 4,953 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2011 through 2019. Of the total, 0 are coded as death reports and 3,846 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 5 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ALCON RESEARCH, LTD. - HUNTINGTON 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 Injury at 3,846 reports (77.6% 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 8 years of MAUDE data, with the peak single-year volume reaching 1,641 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.

4,953
Total Reports
0
Death Reports
3,846
Injury Reports
5
Device Types

Event Types

Injury 3,846 (77.6%)
Malfunction 1,107 (22.4%)

Patient Outcomes

Other 2,681 (46.2%)
Required Intervention 1,924 (33.1%)
R 799 (13.8%)
268 (4.6%)
Hospitalization 77 (1.3%)
O 35 (0.6%)
S 17 (0.3%)
Disability 3 (0.1%)
H 2 (0.0%)

Yearly Trend

11
2011: 17
12
2012: 45
14
2014: 1
15
2015: 1,107
16
2016: 928
17
2017: 1,036
18
2018: 1,641
19
2019: 178

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.