FDAClass IIApril 29, 2020

Alcon Constellation Vision System 20 GA TOTALPLUS recall

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

Why was Alcon Constellation Vision System 20 GA TOTALPLUS 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #2128524H

Product
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon…
Recalling firm
Alcon Research LLC
Quantity
102 packs
Distribution
There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Recall date
April 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls