| Date Initiated by Firm | July 25, 2018 |
|---|
| Create Date | April 23, 2020 |
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| Recall Status1 |
Terminated 3 on April 24, 2020 |
| Recall Number | Z-1794-2020 |
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| 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 |
| FEI Number |
1610287
|
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. |
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FDA Determined
Cause 2 | Employee error |
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| Action | The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product. |
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| Quantity in Commerce | 102 packs |
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| Distribution | There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova. |
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| 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
|
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