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2026 data FDA MAUDE openFDA FDA Class III

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 Class III (highest risk, premarket approval required), regulated under 21 CFR §886.4275 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Aid, Surgical, Viscoelastic LIGHT-BOOK · MAUDE

#416 of 1000 · 2,928 reports · 1994–2026

  • BOOK 2,928 reports
  • RANK #416 of 1000
  • DEATH 1 death-typed
  • INJ 1,992 injury-typed
  • MALF 882 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 #416 of 1000 among tracked device types with 2,928 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 →

Injury-coded reports run above the device-type norm

Aid, Surgical, Viscoelastic carries 68.0% INJURY-coded reports, 37.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 68.0% corpus 30.3% · above corpus mean (+37.7 pp)
  • MALF 30.1% corpus 64.8% · below corpus mean (-34.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 38% of coded problems · Lead manufacturer JOHNSON & JOHNSON SURGICAL VISION, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 62% 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 2,928 MAUDE reports, ranked #416 of 1000.

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

Event Types

Injury 1,992 (68.0%)
Malfunction 882 (30.1%)
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 1,184 (36.2%)
855 (26.1%)
Other 813 (24.9%)
R 198 (6.1%)
O 100 (3.1%)
Hospitalization 59 (1.8%)
S 31 (0.9%)
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 984
Unknown (for use when the device problem is not known) 301
Contamination 297
Device Contamination with Chemical or Other Material 223
Insufficient Device Problem Information 146
Detachment Of Device Component 129
Appropriate Device Problem Term/Code Not Available 85
Use of Device Problem 76
Connection Problem 48
Explanted 40
Reaction 40
Reuse 36
Detachment of Device or Device Component 34
Other (for use when an appropriate device code cannot be identified) 32
Leak/Splash 29
Mechanical Problem 27
Particulates 26
Loose or Intermittent Connection 24
Device Contaminated During Manufacture or Shipping 22
Break 20

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: 113

Reports in 2025 (102) held close to the prior two-year average of 107.

Related Entities for Aid, Surgical, Viscoelastic

Top Manufacturers

JOHNSON & JOHNSON SURGICAL VISION, INC. 246
ABBOTT MEDICAL OPTICS 226
BAUSCH + LOMB 108

Event Locations

1,825 (62.3%)
I 834 (28.5%)
AMBULATORY SURGICAL FACILITY 90 (3.1%)
HOSPITAL 77 (2.6%)
UNKNOWN 35 (1.2%)
INVALID DATA 20 (0.7%)
NO INFORMATION 20 (0.7%)
OUTPATIENT TREATMENT FACILITY 10 (0.3%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Aid, Surgical, Viscoelastic: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,928 here).

Spinal Vertebral Body Replacement Device 2,930 Syringe, Antistick 2,941 Assay, Glycosylated Hemoglobin 2,943 Implanted Subcortical Electrical Stimulator 2,909

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Alarm, Conditioned Response Enuresis 1 Aligner, Sequential 1

Read our methodology - how this data is sourced, computed, and verified.

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.