Z-1794-2020Class II

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

Name: Z-1794-2020 Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The...
Creator: Alcon Research LLC
Published: 2018-07-25
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2018-07-25 / Terminated / root cause: manufacturing process

FDA source

Alcon Research LLC began a recall of Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc... on 2018-07-25. FDA classified it as Class II and gives the reason as "There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1794-2020
Classification: Class II
Status: Terminated
Initiated: 2018-07-25
Posted: 2020-04-23
Terminated: 2020-04-24
Recalling firm: Alcon Laboratories
Product: 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.
Product code: HQC Unit, Phacofragmentation
Reason for recall: There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.
Quantity in commerce: 102 packs
Distribution: There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Product codes and lots: Lot #2128524H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23

Product code HQC

K101285Class IIConstellation Vision SystemAlcon Manufacturing, Ltd. / cleared 2010-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)