Health product recall

Custom-Pak Ophthalmic Surgery Procedure Pack

Last updated

Summary

Product
Custom-Pak Ophthalmic Surgery Procedure Pack
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Custom-Pak Ophthalmic Surgery Procedure Pack More than 10 numbers, contact manufacturer. AS10104-15 AS13781-14 AS15524-09 AS5966-23 AS13781-15 AS18842-02 AS5894-31 AS17055-06 AS0720-75 AS13781-13 AS0720-76 AS13783-04 AS18319-05

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Alcon Laboratories Inc.
6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75313

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