2026 data FDA MAUDE openFDA FDA Class II

Implant, Eye Valve

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 II (moderate risk, special controls required), regulated under 21 CFR §886.3920 (Ophthalmic panel).

FDA MAUDE casebook

openFDA event book Implant, Eye Valve LIGHT-BOOK · MAUDE

#345 of 1000 · 4,379 reports · 1994–2026

  • BOOK 4,379 reports
  • RANK #345 of 1000
  • DEATH 0 death-typed
  • INJ 3,047 injury-typed
  • MALF 1,323 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 516
  • PHOTO Intestinal Stimulator

Nearest event-volume peer: Intestinal Stimulator (3 report gap)

Implant, Eye Valve sits #345 of 1000 among tracked device types with 4,379 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

Implant, Eye Valve carries 69.6% INJURY-coded reports, 39.3pp 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 69.6% corpus 30.3% · above corpus mean (+39.3 pp)
  • MALF 30.2% corpus 64.8% · below corpus mean (-34.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 39% of coded problems · Lead manufacturer JOHNSON & JOHNSON SURGICAL VISION, INC. accounts for 58% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Implant, Eye Valve in the event-volume neighbourhood

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

reports

What this shows Implant, Eye Valve carries 4,379 MAUDE reports, ranked #345 of 1000.

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

Event Types

Injury 3,047 (69.6%)
Malfunction 1,323 (30.2%)
Other 6 (0.1%)
3 (0.1%)

Patient Outcomes

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

Required Intervention 2,279 (47.4%)
Other 1,060 (22.0%)
926 (19.3%)
R 322 (6.7%)
Hospitalization 72 (1.5%)
S 56 (1.2%)
O 47 (1.0%)
Disability 41 (0.9%)
H 4 (0.1%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,588
Complete Blockage 406
Physical Resistance/Sticking 344
Malposition of Device 284
Appropriate Device Problem Term/Code Not Available 154
Migration 150
Mechanical Jam 123
Device Operates Differently Than Expected 113
Device Appears to Trigger Rejection 112
Fracture 100
Insufficient Device Problem Information 96
Break 89
Obstruction of Flow 80
Device Dislodged or Dislocated 78
No Flow 75
Failure to Deliver 70
Partial Blockage 59
Material Twisted/Bent 57
Retraction Problem 37
Occlusion Within Device 36

Yearly Trend

94
1994: 3
97
1997: 2
98
1998: 1
99
1999: 1
00
2000: 2
01
2001: 4
02
2002: 2
03
2003: 13
04
2004: 8
05
2005: 1
06
2006: 8
07
2007: 5
08
2008: 2
09
2009: 4
10
2010: 39
11
2011: 38
12
2012: 116
13
2013: 145
14
2014: 288
15
2015: 205
16
2016: 198
17
2017: 268
18
2018: 258
19
2019: 516
20
2020: 437
21
2021: 412
22
2022: 299
23
2023: 314
24
2024: 364
25
2025: 281
26
2026: 145

Reports in 2025 (281) held close to the prior two-year average of 339.

Related Entities for Implant, Eye Valve

Event Locations

2,247 (51.3%)
I 2,087 (47.7%)
HOSPITAL 21 (0.5%)
NO INFORMATION 14 (0.3%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
UNKNOWN 3 (0.1%)
INVALID DATA 1 (0.0%)

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

Nationwide devices with a comparable report-volume footprint

Implant, Eye Valve carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (4,379 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implant, Eye Valve 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 Implant, Eye Valve; 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.