Alcon Research, Ltd. recalls The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by…

Recall date

April 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1702-2015

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Australia and Canada.

Why it was recalled

The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.