FDA Medical Device Recalls (openFDA)
Alcon Research, LLC: Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
- Recall number
- Z-0260-2024
- Recalling firm
- Alcon Research, LLC
- Product
- Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
- Status
- Open, Classified
- Initiated
- 2023-09-07
- Posted
- 2023-11-07
- Terminated
- not on file
- Reason
- Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- Root cause
- Nonconforming Material/Component
- Action
- On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.
- Quantity
- 120 packs
- Distribution
- US: VA OUS: None
- Lot, serial or model codes
- LOT # : 160NMU, UDI: (01)10380653302278
- 510(k) numbers
- ["K880961"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000117501
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28