Alcon Research, LTD. recalls Constellation Procedure Pak

Recall date

June 28, 2023

Source

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

Recall number

Z-2406-2023

FDA classification

Class II

Brand / firm

Alcon Research, LTD.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, C…

Why it was recalled

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

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

What was recalled

Constellation Procedure Pak