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Health Canada Medical devices

Custom-Pak Ophthalmic Surgery Procedure Pack

Issued July 14, 2023
Issue
Alcon Canada Inc. will be initiating a voluntary medical device recall (advisory) on specific catalog numbers of Alcon Phaco tips & packs containing those Phaco tips. There is a potential for the Phaco tip wrench to generate plastic particles if the Phaco tip is over-tightened to the handpiece. The purpose of the advisory notice is to provide customer guidance when tightening the Phaco tip to mitigate the risk of generating plastic particles that have potential to enter the eye during surgery. Recall start date: June 30, 2023
Hazard description
Performance
Product
Product name
Custom-Pak Ophthalmic Surgery Procedure Pack
Reference
ID
RA-73957