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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 070 09 11 000
Date submitted: 9/25/2011
Manufacturer:Abbott Medical Optics Inc.
Device Type:Optics, Intraocular Lenses (IOLs), Sensar®
Description:Intraocular lenses
Medical Device Identifier:Model: AR40e. Serial Numbers attached.
Reason of Field Safety Corrective Action:A possibility that two specific production orders of Sensar IOLs contain IOLs labeled with the incorrect diopter power.
Remedy Action:Identify any affected serial numbers, STOP using and remove from your inventory. If you have inventory of Sensar IOLs to return, please complete both pages of the Facsimile Form.
Athorized Representative/Importer/Distributor:Gulf Medical Co. Jeddah , (02) 6512828
Report Source:NCMDR
Source Ref. Number:B298768BD331E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Medical Optics Inc - FSN.pdf