Device recall
Z-2287-2020: Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC…
FDA device recall · Class II · Alcon Research LLC
Key facts
| Recall number (Z-number) | Z-2287-2020 |
|---|---|
| Recall event | 85563 |
| Product | 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 OPTIC, PLANAR HAPTICS. |
| Product code | HQL |
| Recalling firm | Alcon Research LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2021 |
| PMA numbers | P930014, P930014S084 |
| FEI number | 1610287 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database