HOYA CORPORATION PENTAX TOKYO OFFICE

Manufacturer adverse-event records for HOYA CORPORATION PENTAX TOKYO OFFICE 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 · 2014–2026 · heavy-book · quiet Death-code · injury-light

Injury-mix signature

HOYA CORPORATION PENTAX TOKYO OFFICE is lighter on Injury codes

Injury-coded event_type share is 1.3% (injury-light tercile) beside 0.06% Death-coded (quiet). Volume band: heavy.

What the Injury-mix reading shows for HOYA CORPORATION PENTAX TOKYO OFFICE

The standout signal for HOYA CORPORATION PENTAX TOKYO OFFICE is Injury-mix: 1.3% Injury-coded (injury-light) beside 0.06% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair HOYA CORPORATION PENTAX TOKYO OFFICE 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 20 device types, led in this extract by Malfunction at 46,463 (98.5% of event_type total). Peak single-year volume reaches 12,912 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

47,155
Total Reports
30
Event-type Death
628
Injury Reports
20
Device Types

Event Types

Malfunction 46,463 (98.5%)
Injury 628 (1.3%)
34 (0.1%)
Death 30 (0.1%)

Patient Outcomes

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

45,999 (96.9%)
Other 452 (1.0%)
Congenital Anomaly 269 (0.6%)
L 190 (0.4%)
H 145 (0.3%)
Required Intervention 131 (0.3%)
Life Threatening 82 (0.2%)
Disability 71 (0.1%)
Hospitalization 57 (0.1%)
O 30 (0.1%)
Death 30 (0.1%)
R 25 (0.1%)
D 5 (0.0%)

Yearly Trend

14
2014: 1
15
2015: 93
16
2016: 151
17
2017: 699
18
2018: 297
19
2019: 2,001
20
2020: 262
21
2021: 3,564
22
2022: 12,447
23
2023: 12,912
24
2024: 9,524
25
2025: 4,699
26
2026: 505