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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §886.4670 (Ophthalmic panel).

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FDA MAUDE casebook

openFDA event book Unit, Phacofragmentation MID-BOOK · MAUDE

#84 of 1000 · 41,218 reports · 1992–2026

  • BOOK 41,218 reports
  • RANK #84 of 1000
  • DEATH 6 death-typed
  • INJ 9,040 injury-typed
  • MALF 31,979 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 3,374
  • PHOTO Catheter, Percutaneous

Nearest event-volume peer: Catheter, Percutaneous (300 report gap)

Unit, Phacofragmentation sits #84 of 1000 among tracked device types with 41,218 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 →

Malfunction reports run above the device-type norm

Unit, Phacofragmentation carries 77.6% MALFUNCTION-coded reports, 12.8pp 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 21.9% corpus 30.3% · below corpus mean (-8.4 pp)
  • MALF 77.6% corpus 64.8% · above corpus mean (+12.8 pp)

Lead product-problem code Failure to Cut is 12% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 32% of manufacturer-tagged reports · Top event location is 59% 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 41,218 MAUDE reports, ranked #84 of 1000.

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

Event Types

Malfunction 31,979 (77.6%)
Injury 9,040 (21.9%)
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.

24,777 (58.3%)
Other 11,707 (27.6%)
Required Intervention 4,387 (10.3%)
R 766 (1.8%)
O 428 (1.0%)
Hospitalization 154 (0.4%)
Disability 136 (0.3%)
S 91 (0.2%)
H 24 (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 3,796
Device Displays Incorrect Message 3,739
Adverse Event Without Identified Device or Use Problem 3,258
Device Operates Differently Than Expected 2,788
Appropriate Device Problem Term/Code Not Available 2,149
Aspiration Issue 1,832
Suction Problem 1,734
Loss of Power 1,566
Device Inoperable 1,537
Device Operational Issue 1,405
Unexpected Shutdown 855
Particulates 833
Operating System Becomes Nonfunctional 807
Failure to Deliver Energy 786
Overheating of Device 744
Decrease in Suction 733
Energy Output Problem 707
Inability to Irrigate 658
Suction Failure 650
Pressure Problem 593

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: 1,941
26
2026: 1,202

Reports in 2025 (1,941) held close to the prior two-year average of 1,992.

Related Entities for Unit, Phacofragmentation

Top Manufacturers

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 10,750
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 8,961
ALCON - IRVINE TECHNOLOGY CENTER 8,727
BAUSCH + LOMB 1,992
ABBOTT MEDICAL OPTICS 1,253
JOHNSON & JOHNSON SURGICAL VISION, INC. 817
BAUSCH & LOMB 652
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE 376

Event Locations

24,328 (59.0%)
I 15,162 (36.8%)
HOSPITAL 1,097 (2.7%)
AMBULATORY SURGICAL FACILITY 374 (0.9%)
OUTPATIENT TREATMENT FACILITY 107 (0.3%)
NO INFORMATION 75 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Unit, Phacofragmentation: 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 (41,218 here).

Catheter, Percutaneous 41,518 Introducer, Catheter 40,656 Clip, Implantable 42,204 Neurological Stereotaxic Instrument 42,726

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 Dilator, Catheter, Ureteral 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.