Drug recall
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert…
FDA recall event 85563 · Class II · Alcon Research LLC
Key facts
| Event ID | 85563 |
|---|---|
| Recall numbers | Z-2287-2020 |
| Recalling firm | Alcon Research LLC |
| Product type | Devices |
| Products | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect IOL diopter |
| Initiation date | Apr 17, 2020 |
| Report date | Jun 17, 2020 |
| Termination date | Feb 5, 2021 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 1610287 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: