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.
FDA Recall Z-1794-2020 · Posted None
Recalling FirmAlcon Research LLC
Recall StatusTerminated
Product CodeHQC
Date Initiated2018-07-25
Date Terminated2020-04-24
Product Quantity102 packs
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.
Firm Action
The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.
Root Cause
Employee error
Distribution Pattern
There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.