Recall Z-2411-2023— Alcon Research, LTD.
Class II · Ongoing
Class II FDA medical device recall by Alcon Research, LTD., initiated 2023-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Alcon Custom 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
Product description
Alcon Custom 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.