FDA Device recall Z-0260-2024
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR by Alcon Research, citing custom surgical procedure packs contain latex gloves but are labeled as "latex free".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0260-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-07 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | VA |
Product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Reason
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
Identifiers
| code_info | LOT # : 160NMU, UDI: (01)10380653302278 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0260-2024%22
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