STAAR SURGICAL COMPANY

Manufacturer adverse-event records for STAAR SURGICAL COMPANY 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 · 1996–2026 · heavy-book · quiet Death-code · injury-heavy

Death-code intensity

STAAR SURGICAL COMPANY is quieter on Death-coded events

Death-coded event_type rows are 3 of 40,998 (0.01% · quiet tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for STAAR SURGICAL COMPANY

The standout signal for STAAR SURGICAL COMPANY is Death-code intensity: 0.01% of 40,998 reports (quiet tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair STAAR SURGICAL COMPANY with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 10 device types, led in this extract by Injury at 30,207 (73.7% of event_type total). Peak single-year volume reaches 5,788 reports across 30 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

40,998
Total Reports
3
Event-type Death
30,207
Injury Reports
10
Device Types

Event Types

Injury 30,207 (73.7%)
Malfunction 10,610 (25.9%)
Other 160 (0.4%)
18 (0.0%)
Death 3 (0.0%)

Patient Outcomes

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

Required Intervention 28,728 (69.9%)
10,711 (26.0%)
Other 1,304 (3.2%)
R 233 (0.6%)
O 35 (0.1%)
S 33 (0.1%)
Disability 18 (0.0%)
Hospitalization 18 (0.0%)
Congenital Anomaly 16 (0.0%)
Life Threatening 7 (0.0%)
H 6 (0.0%)
C 5 (0.0%)
Death 3 (0.0%)
L 2 (0.0%)

Yearly Trend

96
1996: 5
97
1997: 7
99
1999: 3
00
2000: 15
01
2001: 109
02
2002: 90
03
2003: 27
04
2004: 300
05
2005: 363
06
2006: 334
07
2007: 284
08
2008: 230
09
2009: 396
10
2010: 304
11
2011: 689
12
2012: 778
13
2013: 927
14
2014: 1,084
15
2015: 1,404
16
2016: 1,608
17
2017: 1,945
18
2018: 1,847
19
2019: 2,473
20
2020: 3,174
21
2021: 4,947
22
2022: 4,715
23
2023: 5,788
24
2024: 5,317
25
2025: 1,608
26
2026: 227