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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 051 12 12 000
Date submitted: 12/10/2012
Manufacturer:Bausch & Lomb Inc
Device Type:OVD, 27G disposable cannula Amvisc and Amvisc Plus devices
Description:OVD, Amvisc and Amvisc Plus devices
Medical Device Identifier: Model numbers 59051,59081,60081 Model numbers 59051L, 59081L, 60051L, 60081L The OVD containing recalled cannula was manufactured between February 2010 to August 2012 with expiry dates ranging from December 2001 to June 2015
Reason of Field Safety Corrective Action: Some 27G disposable cannulas manufactured by Rhein Medical, Inc. provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The 27G disposable cannulas may leak viscoelastic material or detach from the syringe during injection. Immediate consequences of cannula detachment during intraocular use could include damage to intraocular tissue.
Remedy Action:Remove and destroy affected cannulas and arrange for replacement cannulas
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:B01097AA9D29E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments