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2026 data FDA MAUDE openFDA FDA Class I

Keratome, Ac-Powered

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §886.4370 (Ophthalmic panel).

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FDA MAUDE casebook

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

#224 of 1000 · 9,578 reports · 1994–2026

  • BOOK 9,578 reports
  • RANK #224 of 1000
  • DEATH 0 death-typed
  • INJ 5,296 injury-typed
  • MALF 4,266 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 2,265
  • PHOTO Motor

Nearest event-volume peer: Motor, Drill, Pneumatic (35 report gap)

Keratome, Ac-Powered sits #224 of 1000 among tracked device types with 9,578 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

Keratome, Ac-Powered carries 55.3% INJURY-coded reports, 25.0pp 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 55.3% corpus 30.3% · above corpus mean (+25.0 pp)
  • MALF 44.5% corpus 64.8% · below corpus mean (-20.3 pp)

Lead product-problem code Suction Problem is 46% 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 9,578 MAUDE reports, ranked #224 of 1000.

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

Event Types

Injury 5,296 (55.3%)
Malfunction 4,266 (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.

4,243 (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 4,391
Adverse Event Without Identified Device or Use Problem 4,214
Device Operates Differently Than Expected 164
Unknown (for use when the device problem is not known) 138
Contamination 135
Decrease in Suction 118
Normal 80
Other (for use when an appropriate device code cannot be identified) 57
Device Displays Incorrect Message 45
Reaction 42
Failure to Cut 39
Insufficient Device Problem Information 35
Scratched Material 34
Mechanical Problem 29
Appropriate Device Problem Term/Code Not Available 16
No Apparent Adverse Event 16
Unexpected Therapeutic Results 14
Use of Device Problem 12
Device Issue 10
Misassembled 10

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: 6

Reports in 2025 (10) held close to the prior two-year average of 11.

Related Entities for Keratome, Ac-Powered

Top Manufacturers

ABBOTT MEDICAL OPTICS 5,750
JOHNSON & JOHNSON SURGICAL VISION, INC. 2,170
JOHNSON & JOHNSON SURGICAL VISION, INC 637
BAUSCH & LOMB 195

Event Locations

I 7,697 (80.4%)
1,699 (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 a comparable report-volume footprint

Keratome, Ac-Powered 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 (9,578 here).

Motor, Drill, Pneumatic 9,613 Prosthesis 9,644 Ring, Annuloplasty 9,673 Driver, Prosthesis 9,682

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.