Z-1947-2014Class II

Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon...

Name: Z-1947-2014 Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon...
Creator: Alcon Research, Ltd.
Published: 2014-05-16
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2014-05-16 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The... on 2014-05-16. FDA classified it as Class II and gives the reason as "Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle". 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-1947-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-16
Posted: 2014-06-30
Terminated: 2014-12-09
Recalling firm: Alcon Laboratories
Product: Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Product code: LRO General Surgery Tray
Reason for recall: Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email [email protected]. Customers with questions were instructed to call 1-800-862-5266.
Quantity in commerce: 684 total (525 units in US)
Distribution: Nationwide Distribution including North Carolina and Maine
Product codes and lots: Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-30

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)