Device recall
Z-1291-2023: Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04…
FDA device recall · Class II · Alcon Research, LLC
Key facts
| Recall number (Z-number) | Z-1291-2023 |
|---|---|
| Recall event | 91878 |
| Product | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC… |
| 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