Device recall
Z-0581-2026: CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+…
FDA device recall · Class II · Alcon Research LLC
Key facts
| Recall number (Z-number) | Z-0581-2026 |
|---|---|
| Recall event | 97728 |
| Product | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000… |
| Product code | HQB |
| Recalling firm | Alcon Research LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110951 |
| FEI number | 1610287 |
At a glance
- 1–9 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