Custom-Pak Ophthalmic Surgery Procedure Pack (2015-05-05)

Starting date:

May 5, 2015

Posting date:

June 1, 2015

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-53525

• Reason
• Affected products

Recalled Products

1. Custom-Pak Ophthalmic Surgery Procedure Pack

Reason

Alcon has been informed by Medtronic, Alcon's supplier of the Devon Light Glove, that Medtronic is recalling specific lots of the Devon Light Glove due to the potential for the glove to contain splits and holes. The Devon Light Glove is included in specific builds of Alcon Custom-Pak. Based on the supplier information and recall initiated by the manufacturer of the Devon Light Glove, Alcon has determined that the use of a torn/split light glove, may pose a potential safety risk to the patient. Due to the potential risk from using a torn/split Devon Light Glove, Alcon is recalling all Custom-Paks built with the affected item.

Affected products