Alcon Research LLC recalls Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name o…

Recall date

July 25, 2018

Source

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

Recall number

Z-1794-2020

FDA classification

Class II

Brand / firm

Alcon Research LLC

Sold / distributed

There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.

Why it was recalled

There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.

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

What was recalled

Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.