FDA recall Z-1794-2020

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.

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.

Distribution

There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.

Key facts

Status

Terminated

Initiation date

2018-07-25

Report date

2020-04-29

Termination date

2020-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2020