Alcon Custom Pak

FDA device recall Z-2411-2023 · posted 2023-08-16 · Open, Classified

Recall details

Recalling firm

Alcon Research, LTD.

Reason for recall

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

Action taken

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 related issues are to contact alcon via email at msus.safety@alcon.com or by phone at 1-800-757-9780, Option 5.

Root cause

Process control

Status

Open, Classified

Product code

HQC

Quantity affected

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

Date initiated

2023-06-28

Date posted

2023-08-16

Location

Sinking Spring, PA