ALCON LABORATORIES, INC.

Manufacturer adverse-event records for ALCON LABORATORIES, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1994–2026 · thin-book · quiet Death-code · balanced

Volume signature

ALCON LABORATORIES, INC. is a thinner MAUDE footprint

ALCON LABORATORIES, INC. accounts for 5,465 FDA MAUDE reports (#357 of 434, thin-book tercile). Death-coded event_type share is 0.02% (quiet); Injury share 30.5% (balanced).

What the volume reading shows for ALCON LABORATORIES, INC.

The standout signal for ALCON LABORATORIES, INC. is filing volume: 5,465 adverse-event reports in FDA MAUDE (#357 of 434, thin-book). Death-coded event_type share sits at 0.02% (quiet).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 3,526 (64.5% of event_type total). Peak single-year volume reaches 2,149 reports across 33 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,465
Total Reports
1
Event-type Death
1,669
Injury Reports
20
Device Types

Event Types

Malfunction 3,526 (64.5%)
Injury 1,669 (30.5%)
Other 226 (4.1%)
43 (0.8%)
Death 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,518 (63.3%)
Required Intervention 1,345 (24.2%)
Other 553 (10.0%)
R 50 (0.9%)
Hospitalization 28 (0.5%)
S 24 (0.4%)
Disability 19 (0.3%)
O 12 (0.2%)
Congenital Anomaly 2 (0.0%)
Invalid Data 2 (0.0%)
Life Threatening 2 (0.0%)
H 1 (0.0%)
Death 1 (0.0%)

Yearly Trend

94
1994: 6
95
1995: 17
96
1996: 139
97
1997: 285
98
1998: 1,667
99
1999: 2,149
00
2000: 535
01
2001: 15
02
2002: 16
03
2003: 26
04
2004: 24
05
2005: 13
06
2006: 42
07
2007: 44
08
2008: 25
09
2009: 19
10
2010: 10
11
2011: 17
12
2012: 7
13
2013: 6
14
2014: 11
15
2015: 42
16
2016: 58
17
2017: 54
18
2018: 52
19
2019: 26
20
2020: 19
21
2021: 19
22
2022: 29
23
2023: 16
24
2024: 31
25
2025: 25
26
2026: 21