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2026 data FDA MAUDE openFDA

Unit, Phacofragmentation

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.

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FDA MAUDE casebook

openFDA event book Unit, Phacofragmentation MID-BOOK · MAUDE

#81 of 1000 · 40,288 reports · 1992–2026

  • BOOK 40,288 reports
  • RANK #81 of 1000
  • DEATH 6 death-typed
  • INJ 8,783 injury-typed
  • MALF 31,306 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 3,374
  • PHOTO Catheter, Percutaneous

Nearest event-volume peer: Catheter, Percutaneous (239 report gap)

Unit, Phacofragmentation sits #81 of 1000 among tracked device types with 40,288 MAUDE reports spanning 1992–2026. 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 21.8% corpus 30.4% · below corpus mean (-8.6 pp)
  • MALF 77.7% corpus 64.5% · above corpus mean (+13.2 pp)

Lead product-problem code Failure to Cut is 13% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 30% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Unit, Phacofragmentation in the event-volume neighbourhood

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

reports

What this shows Unit, Phacofragmentation carries 40,288 MAUDE reports, ranked #81 of 1000.

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

Event Types

Malfunction 31,306 (77.7%)
Injury 8,783 (21.8%)
Other 136 (0.3%)
57 (0.1%)
Death 6 (0.0%)

Patient Outcomes

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

24,086 (58.1%)
Other 11,555 (27.9%)
Required Intervention 4,298 (10.4%)
R 726 (1.8%)
O 382 (0.9%)
Hospitalization 151 (0.4%)
Disability 136 (0.3%)
S 91 (0.2%)
H 22 (0.1%)
Death 8 (0.0%)
Invalid Data 4 (0.0%)
Not Applicable 4 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Failure to Cut 2,087
Adverse Event Without Identified Device or Use Problem 1,852
Device Operates Differently Than Expected 1,259
Suction Problem 1,231
Appropriate Term/Code Not Available 869
Unexpected Shutdown 816
Failure to Deliver Energy 763
Loss of Power 710
Energy Output Problem 670
Device Displays Incorrect Message 660
Device Inoperable 640
Decrease in Suction 623
Overheating of Device 619
Suction Failure 581
Aspiration Issue 562
Particulates 543
Inability to Irrigate 436
Operating System Becomes Nonfunctional 390
Insufficient Information 380
Pressure Problem 380

Yearly Trend

92
1992: 10
93
1993: 18
94
1994: 25
95
1995: 34
96
1996: 308
97
1997: 380
98
1998: 169
99
1999: 65
00
2000: 74
01
2001: 55
02
2002: 32
03
2003: 48
04
2004: 135
05
2005: 126
06
2006: 255
07
2007: 341
08
2008: 444
09
2009: 540
10
2010: 2,431
11
2011: 1,802
12
2012: 2,277
13
2013: 2,772
14
2014: 2,740
15
2015: 3,355
16
2016: 3,374
17
2017: 2,781
18
2018: 2,416
19
2019: 2,287
20
2020: 1,217
21
2021: 1,673
22
2022: 1,907
23
2023: 1,799
24
2024: 2,185
25
2025: 1,939
26
2026: 274

Related Entities for Unit, Phacofragmentation

Top Manufacturers

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 10,101
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 8,961
ALCON - IRVINE TECHNOLOGY CENTER 8,727
BAUSCH + LOMB 1,962
ABBOTT MEDICAL OPTICS 1,253
JOHNSON & JOHNSON SURGICAL VISION, INC. 750
BAUSCH & LOMB, INC. 745
BAUSCH & LOMB 652

Event Locations

23,387 (58.0%)
I 15,165 (37.6%)
HOSPITAL 1,095 (2.7%)
AMBULATORY SURGICAL FACILITY 373 (0.9%)
OUTPATIENT TREATMENT FACILITY 107 (0.3%)
NO INFORMATION 86 (0.2%)
INVALID DATA 25 (0.1%)
UNKNOWN 19 (0.0%)
OTHER 18 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
NOT APPLICABLE 4 (0.0%)
AMBULATORY SURGICAL CENTER 3 (0.0%)
HOME 1 (0.0%)

Compare ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER vs ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Unit, Phacofragmentation, 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 (40,288 here).

Catheter, Percutaneous 40,049 Clip, Implantable 41,375 Needle, Hypodermic, Single Lumen 39,044 Mesh 38,574

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Device, Percutaneous Retrieval 6

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

Disclaimer: MAUDE figures for Unit, Phacofragmentation 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 Unit, Phacofragmentation; 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.