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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 045 10 11 000
Date submitted: 10/16/2011
Manufacturer:Abbott Medical Optics Inc.
Device Type:Optical, surgical, Femto second Laser Systems
Description:Optical, surgical, Laser
Medical Device Identifier:Models 2, 3 and iFS
Reason of Field Safety Corrective Action:AMO has identified a minor discrepancy between the user-set depth of corneal tissue incisions and the actual depth of those incisions by way of in vitro testing.
Remedy Action:AMO will be contacting you in the near future to schedule a visit by a Field Service Representative who will adjust your AMO Femto second Laser to correct this cut depth discrepancy. User Action attached.
Athorized Representative/Importer/Distributor:Gulf Medical Co, Jeddah, (02) 6512828
Report Source:NCMDR
Source Ref. Number:3FC00475551CD
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Medical Optics Inc.pdf