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

FDA device recall Z-2470-2012 · posted 2012-09-27 · Terminated

Recall details

Recalling firm

Alcon Research, LTD.

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.

Action taken

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: ReplacementCannulas@alconlabs.com. For questions customers should call 1-800-862-5266.

Root cause

Device Design

Status

Terminated

Product code

NGY

Quantity affected

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.

Date initiated

2012-05-29

Date posted

2012-09-27

Date terminated

2013-02-12

Location

Houston, TX