Recall Z-2411-2023 ยท HQC Unit, Phacofragmentation
Alcon Research, LTD.
Alcon Custom Pak
| Date | Aug 16, 2023 (initiated Jun 28, 2023) |
| Status | Open, Classified |
| Reason | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
| Root cause | Process control |
| Action | Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at Market.Actions@alcon.com. Customers who have experienced any adverse events or quality re |
| Quantity | 1,682,351 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.