2026 data FDA MAUDE openFDA FDA Class I

Aberrometer, Ophthalmic

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 §886.1760 (Ophthalmic panel).

FDA MAUDE casebook

openFDA event book Aberrometer, Ophthalmic LIGHT-BOOK · MAUDE

#803 of 1000 · 649 reports · 2003–2026

  • BOOK 649 reports
  • RANK #803 of 1000
  • DEATH 0 death-typed
  • INJ 341 injury-typed
  • MALF 308 malfunction
  • SPAN 2003–2026
  • PEAK 2018: 148
  • PHOTO Floss, Dental

Nearest event-volume peer: Floss, Dental (0 report gap)

Aberrometer, Ophthalmic sits #803 of 1000 among tracked device types with 649 MAUDE reports spanning 2003–2026. 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

Aberrometer, Ophthalmic carries 52.5% INJURY-coded reports, 22.2pp 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 52.5% corpus 30.3% · above corpus mean (+22.2 pp)
  • MALF 47.5% corpus 64.8% · below corpus mean (-17.4 pp)

Lead product-problem code Incorrect Measurement is 19% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER accounts for 53% of manufacturer-tagged reports · Top event location I is 69% of location-tagged rows .

Aberrometer, Ophthalmic in the event-volume neighbourhood

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

reports

What this shows Aberrometer, Ophthalmic carries 649 MAUDE reports, ranked #803 of 1000.

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

Event Types

Injury 341 (52.5%)
Malfunction 308 (47.5%)

Patient Outcomes

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

Other 327 (44.7%)
187 (25.5%)
Required Intervention 131 (17.9%)
R 66 (9.0%)
O 18 (2.5%)
Disability 2 (0.3%)
S 1 (0.1%)

Top Product Problems

Incorrect Measurement 114
Incorrect, Inadequate or Imprecise Result or Readings 104
Adverse Event Without Identified Device or Use Problem 92
Loose or Intermittent Connection 79
Device Operates Differently Than Expected 55
Insufficient Device Problem Information 32
Appropriate Device Problem Term/Code Not Available 29
Unexpected Therapeutic Results 17
Failure to Align 12
Improper or Incorrect Procedure or Method 12
Overcorrection 7
Power Problem 7
Application Program Problem: Power Calculation Error 6
False Reading From Device Non-Compliance 6
Malposition of Device 6
Therapeutic or Diagnostic Output Failure 6
Device Displays Incorrect Message 5
Improper Device Output 5
Output Problem 5
Patient-Device Incompatibility 5

Yearly Trend

03
2003: 4
16
2016: 22
17
2017: 125
18
2018: 148
19
2019: 71
20
2020: 53
21
2021: 46
22
2022: 38
23
2023: 36
24
2024: 34
25
2025: 39
26
2026: 33

Reports in 2025 (39) held close to the prior two-year average of 35.

Related Entities for Aberrometer, Ophthalmic

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

Nationwide devices with a comparable report-volume footprint

Aberrometer, Ophthalmic 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.

Disclaimer: MAUDE figures for Aberrometer, Ophthalmic 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 Aberrometer, Ophthalmic; 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.