Alcon Research, Ltd. recalls Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgi…

Recall date

August 11, 2015

Source

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

Recall number

Z-1694-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico,…

Why it was recalled

The product has potential to leak beyond their design specification.

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

What was recalled

Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.