Recall Z-1794-2020 ยท HQC Unit, Phacofragmentation
Alcon Research LLC
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.
| Date | Jul 25, 2018 |
| Status | Terminated |
| Reason | 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 | 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 | 102 packs |
| Distribution | There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101285 | CONSTELLATION VISION SYSTEM Alcon Manufacturing, Ltd., Nov 12, 2010 |