Device recall
Z-1606-2024: Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang…
FDA device recall · Class II · Alcon Research, LLC
Key facts
| Recall number (Z-number) | Z-1606-2024 |
|---|---|
| Recall event | 94253 |
| Product | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and… |
| Product code | LRO |
| Recalling firm | Alcon Research, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K880961 |
| FEI number | 1000117501 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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