Product Wiki · Recalls · Health Canada — Medical Devices

Custom-Pak Ophthalmic Surgery Procedure Pack — recall 75313

Health Canada — Medical Devices · Canada · 2024-04-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75313
Date of alert
2024-04-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/custom-pak-ophthalmic-surgery-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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