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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon 20GA TOTALPLUS Combined Procedure Pak

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  Class 2 Device Recall Alcon 20GA TOTALPLUS Combined Procedure Pak see related information
Date Initiated by Firm July 25, 2018
Create Date April 23, 2020
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-1794-2020
Recall Event ID 85198
510(K)Number K101285  
Product Classification Unit, phacofragmentation - Product Code HQC
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.
Code Information Lot #2128524H
Recalling Firm/
Manufacturer		 Alcon Research LLC
6201 South Fwy
Aspex Facility
Fort Worth TX 76134-2099
For Additional Information Contact
817-293-0450
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALCON MANUFACTURING, LTD.
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