Public recall detail

Custom-Pak Ophthalmic Surgery Procedure Pack

2024-04-02

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Recall Safety notice
Quick summary

Quick summary: Custom-Pak Ophthalmic Surgery Procedure Pack. Date: 2024-04-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Custom-Pak Ophthalmic Surgery Procedure Pack. Date: 2024-04-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAlcon Laboratories Inc.
ProductCustom-Pak Ophthalmic Surgery Procedure Pack
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75313

Affected products

ProductCustom-Pak Ophthalmic Surgery Procedure Pack
LotMore than 10 numbers, contact manufacturer.
ModelAS10104-15 AS13781-14 AS15524-09 AS5966-23 AS13781-15 AS18842-02 AS5894-31 AS17055-06 AS0720-75 AS13781-13 AS0720-76 AS13783-04 AS18319-05
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCustom-Pak Ophthalmic Surgery Procedure Pack

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75313
Background{}
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
AudiencesHealthcare
Source updated2024-04-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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