JOHNSON & JOHNSON SURGICAL VISION, INC.

FDA MAUDE device safety record · 2018–2026

What the Data Shows About JOHNSON & JOHNSON SURGICAL VISION, INC.

JOHNSON & JOHNSON SURGICAL VISION, INC. is associated with 9,916 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2018 through 2026. Of the total, 1 is coded as a death report and 6,206 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for JOHNSON & JOHNSON SURGICAL VISION, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 6,206 reports (62.6% 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 9 years of MAUDE data, with the peak single-year volume reaching 3,932 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.

9,916
Total Reports
1
Death Reports
6,206
Injury Reports
20
Device Types

Event Types

Injury 6,206 (62.6%)
Malfunction 3,706 (37.4%)
Other 2 (0.0%)
1 (0.0%)
Death 1 (0.0%)

Patient Outcomes

Required Intervention 5,265 (52.9%)
3,693 (37.1%)
Other 926 (9.3%)
R 27 (0.3%)
Disability 13 (0.1%)
Hospitalization 13 (0.1%)
S 9 (0.1%)
H 2 (0.0%)
O 1 (0.0%)

Yearly Trend

18
2018: 2,704
19
2019: 3,932
20
2020: 2,333
21
2021: 240
22
2022: 110
23
2023: 158
24
2024: 281
25
2025: 142
26
2026: 16

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.