Alcon Research, Ltd.: Medical Device Recall in 2014 - (Recall #: Z-1947-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 16, 2014

Date Posted: July 9, 2014

Recall Number: Z-1947-2014

Event ID: 68335

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

Status: Terminated

Product Quantity: 684 total (525 units in US)

Code Information:

Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.

Distribution Pattern:

Nationwide Distribution including North Carolina and Maine

Voluntary or Mandated:

Voluntary: Firm initiated