Z-1794-2020 Class II Terminated
FDA device recall Z-1794-2020 was initiated by Alcon Research LLC on Jul 25, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 24, 2020). Affected quantity: 102 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 29, 2020
- Initiation Date
- Jul 25, 2018
- Termination Date
- Apr 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 packs
Product Description
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.
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.
Distribution Pattern
There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Code Information
Lot #2128524H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1794-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026