Z-2470-2012Class II

This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar...

Name: Z-2470-2012 This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar...
Creator: Alcon Research, LTD.
Published: 2012-05-29
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2012-05-29 / Terminated / root cause: design

FDA source

Alcon Research, LTD. began a recall of This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items... on 2012-05-29. FDA classified it as Class II and gives the reason as "This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2470-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-09-27
Terminated: 2013-02-12
Recalling firm: Alcon Laboratories
Product: This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
Product code: NGY Cannula, Trocar, Ophthalmic
Reason for recall: This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Alcon sent an Urgent a Voluntary Medical Device Correction letter on May 9, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed NOT to use the affected product, instead customers should use a 1-Count Valved Trocar Cannula and to complete and immediately return the Medical Device Correction Response Form to Alcon via fax at: (817) 916-9087 or email to: [email protected]. For questions customers should call 1-800-862-5266.
Quantity in commerce: 93,319 (30, 413 distributed domestically & 62,906 internationally)
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Product codes and lots: 1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2470-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2470-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

Product code NGY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)