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2026 data FDA MAUDE openFDA

Keratome, Ac-Powered

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

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FDA MAUDE casebook

openFDA event book Keratome, Ac-Powered LIGHT-BOOK · MAUDE

#217 of 1000 · 9,574 reports · 1994–2026

  • BOOK 9,574 reports
  • RANK #217 of 1000
  • DEATH 0 death-typed
  • INJ 5,296 injury-typed
  • MALF 4,262 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 2,265
  • PHOTO Oxygenator

Nearest event-volume peer: Oxygenator, Cardiopulmonary Bypass (68 report gap)

Keratome, Ac-Powered sits #217 of 1000 among tracked device types with 9,574 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 55.3% corpus 30.4% · above corpus mean (+24.9 pp)
  • MALF 44.5% corpus 64.5% · below corpus mean (-20.0 pp)

Lead product-problem code Suction Problem is 55% of coded problems · Lead manufacturer ABBOTT MEDICAL OPTICS accounts for 66% of manufacturer-tagged reports · Top event location I is 80% of location-tagged rows .

Keratome, Ac-Powered in the event-volume neighbourhood

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

reports

What this shows Keratome, Ac-Powered carries 9,574 MAUDE reports, ranked #217 of 1000.

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

Event Types

Injury 5,296 (55.3%)
Malfunction 4,262 (44.5%)
Other 11 (0.1%)
5 (0.1%)

Patient Outcomes

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

4,239 (43.5%)
Required Intervention 4,161 (42.7%)
Other 1,145 (11.7%)
R 166 (1.7%)
Disability 25 (0.3%)
S 11 (0.1%)
L 1 (0.0%)
O 1 (0.0%)
Hospitalization 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Suction Problem 3,887
Adverse Event Without Identified Device or Use Problem 2,855
Decrease in Suction 105
Device Operates Differently Than Expected 100
Device Displays Incorrect Message 36
Scratched Material 30
Mechanical Problem 29
Insufficient Information 11
Appropriate Term/Code Not Available 10
Failure to Cut 10
Device Contamination with Chemical or Other Material 7
Energy Output Problem 4
Unintended Movement 4
Contamination 3
Noise, Audible 3
Patient-Device Incompatibility 3
Smoking 3
Use of Device Problem 3
Accessory Incompatible 2
Break 2

Yearly Trend

94
1994: 4
96
1996: 5
97
1997: 12
98
1998: 13
99
1999: 15
00
2000: 29
01
2001: 30
02
2002: 15
03
2003: 110
04
2004: 19
05
2005: 13
06
2006: 9
07
2007: 32
08
2008: 31
09
2009: 85
10
2010: 84
11
2011: 90
12
2012: 100
13
2013: 353
14
2014: 452
15
2015: 966
16
2016: 1,397
17
2017: 2,112
18
2018: 2,265
19
2019: 816
20
2020: 405
21
2021: 72
22
2022: 7
23
2023: 10
24
2024: 11
25
2025: 10
26
2026: 2

Related Entities for Keratome, Ac-Powered

Top Manufacturers

ABBOTT MEDICAL OPTICS 5,750
JOHNSON & JOHNSON SURGICAL VISION, INC. 2,168
JOHNSON & JOHNSON SURGICAL VISION, INC 637
BAUSCH & LOMB 195

Event Locations

I 7,697 (80.4%)
1,695 (17.7%)
OTHER 84 (0.9%)
OUTPATIENT TREATMENT FACILITY 25 (0.3%)
AMBULATORY SURGICAL FACILITY 22 (0.2%)
HOSPITAL 20 (0.2%)
UNKNOWN 16 (0.2%)
NO INFORMATION 11 (0.1%)
HOME 1 (0.0%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Keratome, Ac-Powered, 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 (9,574 here).

Oxygenator, Cardiopulmonary Bypass 9,642 Prosthesis 9,486 Plate, Bone 9,475 Ring, Annuloplasty 9,471

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Keratome, Ac-Powered 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 Keratome, Ac-Powered; 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.