FDA-Device2020-04-29Class II
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.
Alcon Research LLC
Hazard
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
Sold states
There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
Affected count
102 packs
Manufactured in
6201 South Fwy, Aspex Facility, Fort Worth, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2020Don't want to check this manually?
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