Recall Z-2409-2023— Alcon Research, LTD.

Name: FDA recall Z-2409-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-28

Class II · Ongoing

Class II FDA medical device recall by Alcon Research, LTD., initiated 2023-06-28. It names one FDA 510(k) clearance: K191650. Product: Legion FMS Pak. Reason: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench..

Recalling firm: Alcon Research, LTD.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-28
Firm location: Sinking Spring, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K191650 — LEGION SystemAlcon Research, LLC·cleared 2019-11-01

K-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

Legion FMS Pak

Reason for recall

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Data sourced from openFDA. This site is unofficial and independent of the FDA.