Recall Z-1794-2020— Alcon Research LLC
Class II · Terminated
Class II FDA medical device recall by Alcon Research LLC, initiated 2018-07-25, terminated 2020-04-24. It names one FDA 510(k) clearance: K101285. 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: There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-25
- Terminated
- 2020-04-24
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.