Recall Z-1794-2020
Alcon Research LLC · initiated July 25, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #2128524H
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: Employee error
Action taken
The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.
Details
- Recall number
- Z-1794-2020
- Initiated
- July 25, 2018
- Terminated
- April 24, 2020
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 102 packs
- Distribution
- There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
- Recalling firm
- Alcon Research LLC, Fort Worth, TX