Alcon Research, Ltd. recalls INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An o…

Recall date

October 6, 2014

Source

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

Recall number

Z-1597-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Nationwide Distribution.

Why it was recalled

The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

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

What was recalled

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.