Accessories, Soft Lens Products
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 §886.5928 (Ophthalmic panel).
FDA MAUDE casebook
openFDA event book Accessories, Soft Lens Products LIGHT-BOOK · MAUDE
#244 of 1000 · 8,031 reports · 1993–2026
- BOOK 8,031 reports
- RANK #244 of 1000
- DEATH 2 death-typed
- INJ 4,074 injury-typed
- MALF 3,240 malfunction
- SPAN 1993–2026
- PEAK 2017: 2,666
- PHOTO Set
Nearest event-volume peer: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (20 report gap)
Accessories, Soft Lens Products sits #244 of 1000 among tracked device types with 8,031 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 →
Malfunction reports sit below the device-type norm
Accessories, Soft Lens Products carries 40.3% MALFUNCTION-coded reports, 24.5pp below 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 50.7% corpus 30.3% · above corpus mean (+20.4 pp)
- MALF 40.3% corpus 64.8% · below corpus mean (-24.5 pp)
Lead product-problem code Product Quality Problem is 36% of coded problems · Lead manufacturer BAUSCH & LOMB INCORPORATED accounts for 80% of manufacturer-tagged reports · Top event location is 42% of location-tagged rows .
Accessories, Soft Lens Products in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Dermatome
Dermatome
8,121 reports
- Prosthesis
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
8,110 reports
- Accessories (this)
Accessories, Soft Lens Products
8,031 reports
- Set
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
8,011 reports
- Lens
Lens, Intraocular, Toric Optics
7,999 reports
- Catheter
Catheter, Ultrasound, Intravascular
7,853 reports
What this shows Accessories, Soft Lens Products carries 8,031 MAUDE reports, ranked #244 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 fell to 47 in 2025, down from an average of 82 in the two years before.
Related Entities for Accessories, Soft Lens Products
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Accessories, Soft Lens Products: 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 (8,031 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Accessories, Soft Lens Products 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 Accessories, Soft Lens Products; 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.