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Recall Observatory FDA recall evidence

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

July 25, 2018

Class II

Product summary

Firm
Alcon Research LLC
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

    reason.no_named_rule · v1.0.0

    There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.