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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 056 06 12 000
Date submitted: 6/11/2012
Manufacturer:Alcon Laboratories Inc
Device Type:Single use consumable items, Alcon 23G Non‐Valved Trocar Cannula and Infusion Cannula
Description:Single use consumable items.
Medical Device Identifier:(1) 23G TotalPLUS® Pak (2) 23G Combined Procedure Pack, 0.9mm (attached)
Reason of Field Safety Corrective Action:Alcon confirmed complaints for the 23G non‐valved trocar cannula and infusion cannula related to a loose fit between the non‐valved trocar cannula and infusion cannula. This loose fit may cause the infusion cannula to dislodge from the trocar cannula during the surgical procedure, which may eliminate the necessary infusion to the eye required to maintain adequate pressure while operating
Remedy Action:Customers advised to: •NOT to use the non‐valved trocar cannula for infusion. To minimize disruption and ensure continuous patient care, replacement valved trocar cannulas will be provided to your facility at no charge. •Customers should follow these important steps for utilizing their replacement valved trocar cannula: 1) Review your inventory of Alcon products to determine if you have any of the impacted products in stock. 2) Please complete and return the attached Response form to Alcon . 3) Upon opening an impacted product, Health Care Professionals should use a single valved trocar cannula (grey handle) for the INFUSION CANNULA ONLY, in PLACE OF the non‐valved trocar cannula (black handle). 4) Discard the unsused non‐valved trocar cannula (black handle).
Athorized Representative/Importer/Distributor:AL-KAMAL Import, Riyadh, (01) 2181122
Report Source:NCAR
Source Ref. Number:UK-2012-31-05-102
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Alcon Laboratories Inc.pdf