Alcon Research, Ltd. recalls Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Number

Recalled July 9, 2014 · FDA recall Z-1947-2014 · Alcon Research

Hazard

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 · FDA Class II

Units

684 total (525 units in US)

Sold at

Nationwide Distribution including North Carolina and Maine

Description

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

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.

Manufacturer(s)

Alcon Research, Ltd.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →