Reported Apr 29, 2020 · Terminated

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

Alcon Research LLC

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 LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot #2128524H
Amount recalled
102 packs

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.

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 Apr 24, 2020 · Data as of Sep 19, 6:17 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.