Z-0260-2024Class II

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Name: Z-0260-2024 Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Creator: Alcon Research, LLC
Published: 2023-09-07
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2023-09-07 / Open, Classified / root cause: manufacturing process

FDA source

Alcon Research, LLC began a recall of Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR on 2023-09-07. FDA classified it as Class II and gives the reason as "Custom surgical procedure packs contain latex gloves but are labeled as "latex free"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0260-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-07
Posted: 2023-11-07
Recalling firm: Alcon Laboratories
Product: Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Product code: LRO General Surgery Tray
Reason for recall: Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
Root cause tag: manufacturing process
FDA 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 in commerce: 120 packs
Distribution: US: VA OUS: None
Product codes and lots: LOT # : 160NMU, UDI: (01)10380653302278

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0260-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0260-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07

Product code LRO

K880961Class IIAlcon Surgical Procedure PacksAlcon Laboratories / cleared 1988-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)