2026 data FDA MAUDE openFDA

Aid, Surgical, Viscoelastic

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 Aid, Surgical, Viscoelastic LIGHT-BOOK · MAUDE

#411 of 1000 · 2,845 reports · 1994–2026

  • BOOK 2,845 reports
  • RANK #411 of 1000
  • DEATH 1 death-typed
  • INJ 1,947 injury-typed
  • MALF 844 malfunction
  • SPAN 1994–2026
  • PEAK 2008: 203
  • PHOTO Spinal Vertebral Body…

Nearest event-volume peer: Spinal Vertebral Body Replacement Device (2 report gap)

Aid, Surgical, Viscoelastic sits #411 of 1000 among tracked device types with 2,845 MAUDE reports spanning 1994–2026. 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 68.4% corpus 30.4% · above corpus mean (+38.0 pp)
  • MALF 29.7% corpus 64.5% · below corpus mean (-34.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 53% of coded problems · Lead manufacturer JOHNSON & JOHNSON SURGICAL VISION, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Aid, Surgical, Viscoelastic in the event-volume neighbourhood

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

reports

What this shows Aid, Surgical, Viscoelastic carries 2,845 MAUDE reports, ranked #411 of 1000.

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

Event Types

Injury 1,947 (68.4%)
Malfunction 844 (29.7%)
Other 31 (1.1%)
22 (0.8%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 1,164 (36.8%)
818 (25.8%)
Other 790 (24.9%)
R 186 (5.9%)
O 91 (2.9%)
Hospitalization 57 (1.8%)
S 31 (1.0%)
H 15 (0.5%)
Disability 10 (0.3%)
Life Threatening 3 (0.1%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 714
Contamination 184
Device Contamination with Chemical or Other Material 107
Insufficient Information 72
Appropriate Term/Code Not Available 48
Detachment of Device or Device Component 28
Device Contaminated During Manufacture or Shipping 22
Difficult to Remove 18
Leak/Splash 17
Mechanical Problem 17
Particulates 17
Disconnection 16
Delivered as Unsterile Product 15
Manufacturing, Packaging or Shipping Problem 14
Contamination /Decontamination Problem 12
Patient-Device Incompatibility 11
Defective Component 10
Device Operates Differently Than Expected 10
Device Handling Problem 9
Break 7

Yearly Trend

94
1994: 15
95
1995: 7
96
1996: 30
97
1997: 56
98
1998: 32
99
1999: 40
00
2000: 53
01
2001: 42
02
2002: 19
03
2003: 27
04
2004: 19
05
2005: 61
06
2006: 90
07
2007: 58
08
2008: 203
09
2009: 34
10
2010: 157
11
2011: 106
12
2012: 140
13
2013: 83
14
2014: 119
15
2015: 68
16
2016: 136
17
2017: 162
18
2018: 113
19
2019: 156
20
2020: 132
21
2021: 157
22
2022: 184
23
2023: 107
24
2024: 107
25
2025: 102
26
2026: 30

Related Entities for Aid, Surgical, Viscoelastic

Event Locations

1,742 (61.2%)
I 834 (29.3%)
AMBULATORY SURGICAL FACILITY 90 (3.2%)
HOSPITAL 77 (2.7%)
UNKNOWN 35 (1.2%)
INVALID DATA 20 (0.7%)
NO INFORMATION 20 (0.7%)
OUTPATIENT TREATMENT FACILITY 10 (0.4%)
OTHER 9 (0.3%)
NOT APPLICABLE 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
HOME 1 (0.0%)

Compare JOHNSON & JOHNSON SURGICAL VISION, INC. vs ABBOTT MEDICAL OPTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Aid, Surgical, Viscoelastic, 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 (2,845 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Aid, Surgical, Viscoelastic 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 Aid, Surgical, Viscoelastic; 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.