BAUSCH & LOMB, INC.

FDA MAUDE device safety record · 1995–2020

What the Data Shows About BAUSCH & LOMB, INC.

BAUSCH & LOMB, INC. is associated with 3,554 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1995 through 2020. Of the total, 0 are coded as death reports and 1,714 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, INC. 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 Malfunction at 1,819 reports (51.2% 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 24 years of MAUDE data, with the peak single-year volume reaching 685 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.

3,554
Total Reports
0
Death Reports
1,714
Injury Reports
20
Device Types

Event Types

Malfunction 1,819 (51.2%)
Injury 1,714 (48.2%)
18 (0.5%)
Other 3 (0.1%)

Patient Outcomes

1,822 (49.3%)
Required Intervention 1,368 (37.0%)
Other 261 (7.1%)
R 121 (3.3%)
Hospitalization 98 (2.7%)
S 14 (0.4%)
Disability 7 (0.2%)
O 6 (0.2%)
Death 1 (0.0%)

Yearly Trend

95
1995: 1
96
1996: 1
97
1997: 10
98
1998: 10
99
1999: 11
00
2000: 4
01
2001: 5
02
2002: 48
03
2003: 318
04
2004: 398
05
2005: 119
06
2006: 685
07
2007: 482
08
2008: 171
09
2009: 20
10
2010: 14
11
2011: 64
12
2012: 156
13
2013: 268
14
2014: 252
15
2015: 509
18
2018: 2
19
2019: 5
20
2020: 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.