2026 data FDA MAUDE openFDA

Accessories, Soft Lens Products

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Accessories, Soft Lens Products LIGHT-BOOK · MAUDE

#239 of 1000 · 7,993 reports · 1993–2026

  • BOOK 7,993 reports
  • RANK #239 of 1000
  • DEATH 2 death-typed
  • INJ 4,044 injury-typed
  • MALF 3,234 malfunction
  • SPAN 1993–2026
  • PEAK 2017: 2,666
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Peripheral, Atherectomy (15 report gap)

Accessories, Soft Lens Products sits #239 of 1000 among tracked device types with 7,993 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 50.6% corpus 30.4% · above corpus mean (+20.2 pp)
  • MALF 40.5% corpus 64.5% · below corpus mean (-24.0 pp)

Lead product-problem code Product Quality Problem is 78% of coded problems · Lead manufacturer BAUSCH & LOMB INCORPORATED accounts for 71% of manufacturer-tagged reports · Top event location is 42% of location-tagged rows .

Accessories, Soft Lens Products in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Accessories, Soft Lens Products carries 7,993 MAUDE reports, ranked #239 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 4,044 (50.6%)
Malfunction 3,234 (40.5%)
Other 531 (6.6%)
182 (2.3%)
Death 2 (0.0%)

Patient Outcomes

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

3,819 (42.8%)
Other 1,972 (22.1%)
Required Intervention 1,587 (17.8%)
S 377 (4.2%)
R 375 (4.2%)
Hospitalization 350 (3.9%)
Disability 257 (2.9%)
O 167 (1.9%)
Life Threatening 13 (0.1%)
L 6 (0.1%)
H 1 (0.0%)

Top Product Problems

Product Quality Problem 2,900
Adverse Event Without Identified Device or Use Problem 346
Improper or Incorrect Procedure or Method 62
Device Markings/Labelling Problem 53
Patient-Device Incompatibility 52
Insufficient Information 47
Device Operates Differently Than Expected 44
Contamination 31
Device Emits Odor 29
Use of Device Problem 22
Labelling, Instructions for Use or Training Problem 19
Appropriate Term/Code Not Available 17
Material Integrity Problem 15
Packaging Problem 14
Device Handling Problem 10
Patient Device Interaction Problem 9
Contamination /Decontamination Problem 8
Improper Chemical Reaction 6
Manufacturing, Packaging or Shipping Problem 6
Defective Device 5

Yearly Trend

93
1993: 2
94
1994: 7
95
1995: 7
96
1996: 20
97
1997: 47
98
1998: 36
99
1999: 23
00
2000: 14
01
2001: 25
02
2002: 30
03
2003: 35
04
2004: 45
05
2005: 30
06
2006: 1,355
07
2007: 1,151
08
2008: 153
09
2009: 121
10
2010: 241
11
2011: 273
12
2012: 268
13
2013: 84
14
2014: 105
15
2015: 176
16
2016: 498
17
2017: 2,666
18
2018: 95
19
2019: 60
20
2020: 82
21
2021: 51
22
2022: 62
23
2023: 84
24
2024: 80
25
2025: 47
26
2026: 20

Related Entities for Accessories, Soft Lens Products

Event Locations

3,331 (41.7%)
I 3,209 (40.1%)
HOME 1,031 (12.9%)
NO INFORMATION 314 (3.9%)
UNKNOWN 55 (0.7%)
OTHER 20 (0.3%)
HOSPITAL 16 (0.2%)
INVALID DATA 11 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare BAUSCH & LOMB INCORPORATED vs BAUSCH & LOMB →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Accessories, Soft Lens Products, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (7,993 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Accessories, Soft Lens Products are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Accessories, Soft Lens Products; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.