BAUSCH & LOMB

FDA MAUDE device safety record · 1994–2025

What the Data Shows About BAUSCH & LOMB

BAUSCH & LOMB is associated with 8,705 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1994 through 2025. Of the total, 0 are coded as death reports and 4,420 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 BAUSCH & LOMB should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Injury at 4,420 reports (50.8% of total). Patient-outcome categorizations are reported across 11 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 25 years of MAUDE data, with the peak single-year volume reaching 1,886 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.

8,705
Total Reports
0
Death Reports
4,420
Injury Reports
20
Device Types

Event Types

Injury 4,420 (50.8%)
Malfunction 4,163 (47.8%)
Other 88 (1.0%)
34 (0.4%)

Patient Outcomes

4,294 (47.3%)
Required Intervention 3,115 (34.3%)
Other 1,110 (12.2%)
S 183 (2.0%)
Hospitalization 115 (1.3%)
R 109 (1.2%)
O 79 (0.9%)
Disability 64 (0.7%)
Death 5 (0.1%)
Life Threatening 5 (0.1%)
L 1 (0.0%)

Yearly Trend

94
1994: 1
96
1996: 3
97
1997: 1
01
2001: 142
02
2002: 401
03
2003: 693
04
2004: 94
05
2005: 16
06
2006: 1,886
07
2007: 1,282
08
2008: 1,180
09
2009: 402
10
2010: 393
11
2011: 408
12
2012: 332
13
2013: 361
14
2014: 263
15
2015: 834
16
2016: 4
17
2017: 1
18
2018: 1
19
2019: 1
20
2020: 2
21
2021: 3
25
2025: 1

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.