Lens, Guide, Intraocular
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 §886.4300 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Lens, Guide, Intraocular LIGHT-BOOK · MAUDE
#233 of 1000 · 8,686 reports · 1996–2026
- BOOK 8,686 reports
- RANK #233 of 1000
- DEATH 0 death-typed
- INJ 1,576 injury-typed
- MALF 7,075 malfunction
- SPAN 1996–2026
- PEAK 2001: 1,294
- PHOTO Stent, Carotid
Nearest event-volume peer: Stent, Carotid (37 report gap)
Lens, Guide, Intraocular sits #233 of 1000 among tracked device types with 8,686 MAUDE reports spanning 1996–2026. 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
Lens, Guide, Intraocular carries 81.5% MALFUNCTION-coded reports, 16.6pp 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 18.1% corpus 30.3% · below corpus mean (-12.1 pp)
- MALF 81.5% corpus 64.8% · above corpus mean (+16.6 pp)
Lead product-problem code Sticking is 18% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HUNTINGTON accounts for 28% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .
Lens, Guide, Intraocular in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter
Catheter, Electrode Recording, Or Probe, Electrode Recording
8,756 reports
- Lens (this)
Lens, Guide, Intraocular
8,686 reports
- Stent, Carotid
Stent, Carotid
8,649 reports
- Catheter
Catheter, Thrombus Retriever
8,617 reports
- Guide
Guide, Surgical, Instrument
8,485 reports
- Catheter
Catheter, Peripheral, Atherectomy
8,451 reports
What this shows Lens, Guide, Intraocular carries 8,686 MAUDE reports, ranked #233 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (433) held close to the prior two-year average of 360.
Related Entities for Lens, Guide, Intraocular
Top Manufacturers
Event Locations
Compare ALCON RESEARCH, LLC - HUNTINGTON vs STAAR SURGICAL CO. →
Nationwide devices with a comparable report-volume footprint
Lens, Guide, Intraocular 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 (8,686 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Lens, Guide, Intraocular 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 Lens, Guide, Intraocular; 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.