Device 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.
Z-1794-2020
Product summary
- Event
- Event 85198
- Status
- Terminated
- Classification
- Class II
- Quantity
- 102 packs
- Official record key
device-enforcement:Z-1794-2020
Official wording
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.
Code information: Lot #2128524H
Distribution pattern: There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Derived failure modes
-
Unknown
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.