Reported May 11, 2016 · Terminated

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An…

Alcon Research, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099

Is this the product you have?

  • INFINITI Ultrasound Pack
  • Catalog Numbers8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts
Lot codes and dates
  • Lot numbers
    • 1623139H
    • 1623140H
    • 1623138H
    • 1623141H
    • 1623765H
    • 1623148H
    • 1623766H
    • 1623767H
    • 1623768H
    • 1623142H
Amount recalled
6597 packs

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 31, 2017 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.