Lenses, Soft Contact, Extended Wear
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 §886.5925 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Lenses, Soft Contact, Extended Wear LIGHT-BOOK · MAUDE
#404 of 1000 · 3,063 reports · 1993–2026
- BOOK 3,063 reports
- RANK #404 of 1000
- DEATH 0 death-typed
- INJ 2,948 injury-typed
- MALF 42 malfunction
- SPAN 1993–2026
- PEAK 2016: 220
- PHOTO Agent
Nearest event-volume peer: Agent, Injectable, Embolic (1 report gap)
Lenses, Soft Contact, Extended Wear sits #404 of 1000 among tracked device types with 3,063 MAUDE reports spanning 1993–2026. 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
Lenses, Soft Contact, Extended Wear carries 96.2% INJURY-coded reports, 66.0pp 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 96.2% corpus 30.3% · above corpus mean (+66.0 pp)
- MALF 1.4% corpus 64.8% · below corpus mean (-63.5 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 39% of coded problems · Lead manufacturer BAUSCH & LOMB INCORPORATED accounts for 100% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .
Lenses, Soft Contact, Extended Wear in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Esophageal
3,094 reports
- Test
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
3,089 reports
- Accelerator
Accelerator, Linear, Medical
3,068 reports
- Lenses (this)
Lenses, Soft Contact, Extended Wear
3,063 reports
- Agent
Agent, Injectable, Embolic
3,062 reports
- Prosthesis
Prosthesis, Elbow, Constrained, Cemented
3,057 reports
What this shows Lenses, Soft Contact, Extended Wear carries 3,063 MAUDE reports, ranked #404 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 (116) held close to the prior two-year average of 141.
Related Entities for Lenses, Soft Contact, Extended Wear
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Lenses, Soft Contact, Extended Wear 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 (3,063 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 Lenses, Soft Contact, Extended Wear 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 Lenses, Soft Contact, Extended Wear; 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.