Custom-Pak Ophthalmic Surgery Procedure Pack (2021-02-02)

Starting date:

February 2, 2021

Posting date:

February 12, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74993

Last updated:
2021-04-15

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  Reason
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  Affected products

Affected Products 

Custom-Pak Ophthalmic Surgery Procedure Pack

Reason

Alcon has received reports of mold residue on the pull tags of extra-large (XL) gowns included in specific Alcon Custom-Pak lots. The issue impacts 2 lots of surgical gowns received from a third party supplier prior to inclusion within alcon Custom-Pak Lots and before sterilization. Analysis has concluded that the residue on the pull tags and gowns is non-viable. However, out of an abundance of caution, Alcon is immediately removing all affected (60 units) of Custom-Pak lots from the market.

Affected products