Z-0053-2018Class II

Alcon Custom Pak

Name: Z-0053-2018 Alcon Custom Pak
Creator: Alcon Research, LTD.
Published: 2017-08-08
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2017-08-08 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, LTD. began a recall of Alcon Custom Pak on 2017-08-08. FDA classified it as Class II and gives the reason as "Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0053-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-08
Posted: 2017-08-25
Terminated: 2019-08-05
Recalling firm: Alcon Laboratories
Product: Alcon Custom Pak
Product code: LRO General Surgery Tray
Reason for recall: Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
Quantity in commerce: 33 units
Distribution: States in the US - WI, NY, MO
Product codes and lots: 2033459H, 2034186H, 2034491H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0053-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0053-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)