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Health Canada Medical devices

Custom-Pak Ophthalmic Surgery Procedure Pack

Issued April 2, 2024
Issue
On March 14, 2024 Alcon Canada was notified of customer complaints for foreign material, occlusions and bent tips for oasis medical 27g chang hydrodissection cannulas, a component within Alcon Custom Pak. Due to the potential for an increased risk of inflammation & ocular tissue damage, Alcon has decided to perform a voluntary medical device field correction ( type II) as the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences. Recall start date: March 18, 2024
Hazard description
Performance
Product
Product name
Custom-Pak Ophthalmic Surgery Procedure Pack
Reference
ID
RA-75313