Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recalled by Alcon Research LLC Due to There was a potential that a 25-gauge infusion...

Date: July 25, 2018
Company: Alcon Research LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research LLC directly.

Affected Products

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.

Quantity: 102 packs

Why Was This 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.

Where Was This Sold?

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

About Alcon Research LLC

Alcon Research LLC has 59 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report