Intraocular Lens
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 III (highest risk, premarket approval required), regulated under 21 CFR §886.3600 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Intraocular Lens MID-BOOK · MAUDE
#47 of 1000 · 79,358 reports · 1992–2026
- BOOK 79,358 reports
- RANK #47 of 1000
- DEATH 4 death-typed
- INJ 34,033 injury-typed
- MALF 41,831 malfunction
- SPAN 1992–2026
- PEAK 2025: 5,388
- PHOTO Analyzer
Nearest event-volume peer: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (486 report gap)
Intraocular Lens sits #47 of 1000 among tracked device types with 79,358 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 →
Injury-coded reports run above the device-type norm
Intraocular Lens carries 42.9% INJURY-coded reports, 12.6pp 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 42.9% corpus 30.3% · above corpus mean (+12.6 pp)
- MALF 52.7% corpus 64.8% · below corpus mean (-12.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Lead manufacturer AMO PUERTO RICO MFG. INC. accounts for 17% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Intraocular Lens in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Electrical, Implantable, For Incontinence
82,555 reports
- Orthopedic Ma…
Orthopedic Manual Surgical Instrument
81,214 reports
- Intraocular L… (this)
Intraocular Lens
79,358 reports
- Analyzer
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
78,872 reports
- Colonoscope A…
Colonoscope And Accessories, Flexible/Rigid
78,298 reports
- Aortic Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
78,144 reports
What this shows Intraocular Lens carries 79,358 MAUDE reports, ranked #47 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 (5,388) held close to the prior two-year average of 4,034.
Related Entities for Intraocular Lens
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Intraocular Lens: 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 (79,358 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Intraocular Lens 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 Intraocular Lens; 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.